—#200962

Product

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIO, Model Number: DYNJ902507B; b. ANGIO BASIN SET, Model Numbers: DYNJ46043D, DYNJ46043F; c. ANGIO CATH COMBINED PACK, Model Numbers: DYNJ43609K, DYNJ43609L, DYNJ43609M, DYNJ43609N; d. ANGIO DRAPE PACK, Model Number: DYNJ17624B, DYNJ44320F; e. ANGIO DRAPE SPEC PROC PACK, Model Number: DYNJ47951A; f. ANGIO LEFT HEART PACK, Model Number: DYNJ40632C; g. ANGIO PACK, Model Numbers: DYNJ30141, DYNJ34361, DYNJ42903B, DYNJ43661B, DYNJ47226A, DYNJ50624A, DYNJ51239A, DYNJ58111C, DYNJ58126A, DYNJ62299, DYNJ62544, DYNJ65043A, DYNJ66398A, DYNJ66398B; h. ANGIO PACK 2-A, Model Number: DYNJ60507A; i. ANGIO PACK-LF, Model Numbers: DYNJ0373279L, DYNJ0373279M; j. ANGIO TRAY, Model Numbers: DYNJ46153A, DYNJ46153B, DYNJ52121; k. ANGIO TRAY W/CHLORAPREP, Model Number: DYNJ62742; l. ANGIO/PICC PACK, Model Number: DYNJ36049; m. ANGIOGRAM, Model Number: DYNJ0149444M; n. ANGIOGRAM PACK, Model Numbers: DYNJ45007, DYNJ47004C, DYNJ66244; o. ANGIOGRAM TRAY, Model Number: DYNJ33638K; p. ANGIOGRAPHY DRAPE PACK, Model Numbers: DYNJ49621B, DYNJ63060A, DYNJ63684F, DYNJ68065, DYNJ68065A, DYNJT2344B; q. ANGIOGRAPHY DRAPE PACK-LF, Model Numbers: DYNJ28067G, DYNJVB1135A; r. ANGIOGRAPHY DRP PK PEDI CATH, Model Numbers: 00-401318L, 00-401318M; s. ANGIOGRAPHY OR, Model Number: CDS984944C; t. ANGIOGRAPHY PACK, Model Numbers: DYNJ44293D, DYNJ47906, DYNJ55252B, DYNJ57498, DYNJ65190C, DYNJ66476, DYNJC2371G; u. ANGIOGRAPHY PACK-LF, Model Number: DYNJ0854485T; v. ANGIOPLASTY PACK-LF, Model Numbers: DYNJ43203F, DYNJ64655A; w. CATH LAB PACK, Model Number: DYNJ65185; x. CLOVIS CATH LAB PACK, Model Number: DYNJ62379; y. CUSTOM ANGIO TRAY, Model Number: DYNJ41649F; z. CVOR ANGIOGRAPHY PACK-LF, Model Number: DYNJ42367A; aa. DASHTI-YAO NEURO ANGIO-LF, Model Number: DYNJ33457C; bb. DBD-ANGIO TRAY, Model Number: DYNJ68758; cc. DBD-CATH PACK, Model Number: DYNJ63527; dd. DBD-CLOVIS CATH LAB PACK, Model Number: DYNJ62379; ee. DEPAUL ANGIO PACK, Model Number: DYNJ19939M; ff. EH VASCULAR ANGIO, Model Number: DYNJ49931F; gg. ENDOVASCULAR KIT, Model Number: DYNJ906354C; hh. EP ANGIOGRAPHY PACK, Model Number: DYNJ24225K; ii. FEMORAL ANGIOGRAPY SET UP, Model Number: DYNJ61015B; jj. FS ANGIO, Model Number: DYNJ42499C; kk. GENERAL ANGIO PACK, Model Number: DYNJ57760B; ll. HH ANGIO PACK, Model Number: DYNJ59465B; mm. IPMC ANGIOGRAPHY PACK-LF, Model Number: DYNJ0806254D; nn. IR MINOR ANGIO PACK, Model Number: DYNJ37665B; oo. KENNESTONE ANGIO, Model Number: WK100B; pp. MH HOOD CARDIAC ANGIO, Model Numbers: DYNJ49884B, DYNJ49884F; qq. MV-IR ANGIO DRAPE PACK-LF, Model Number: DYNJ41553D; rr. OR ANGIO PACK, Model Number: DYNJ60319A; ss. OR ANGIOGRAPHY PACK, Model Number: DYNJ67245; tt. PACK,BASIC ANGIO, Model Number: DYNJ65482A; uu. PEDI ANGIO PACK-LF, Model Number: PHS41743D; vv. PEDIATRIC CATH ANGIO PACK, Model Numbers: DYNJ54755D, DYNJ54755F; ww. PERCUTANEOUS ANGIO CHRG, Model Number: DYNJ60112; xx. PERCUTANEOUS ANGIO PACK-LF, Model Numbers: DYNJ57645A, DYNJ57645B; yy. PORT PACK, Model Number: DYNJ61747A; zz. SUNSHINE PACK, Model Number: DYNJ64830; aaa. SURGERY ANGIO PACK-LF, Model Number: DYNJ66500; bbb. VASCULAR ANGIO PACK-LF, Model Numbers: DYNJ0201109AG

FDA product code: OEQ — Angiography/Angioplasty Kit
Device class: Class 2
Medical specialty: Cardiovascular
Affected lot / code info: All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNJ902507B, UPC Number: 088994278118. b. Model Number: DYNJ46043D, UPC Number: 019348935036; Model Number: DYNJ46043F, UPC Number: 019348985672. c. Model Number: DYNJ43609K, UPC Number: 019348950140; Model Number: DYNJ43609L, UPC Number 019348960178; Model Number: DYNJ43609M, UPC Number 019348962744; Model Number: DYNJ43609N, UPC Number 019348928212. d. Model Number: DYNJ17624B, UPC Number: 019348986729; Model Number: DYNJ44320F, UPC Number 019348943551. e. Model Number: DYNJ47951A, UPC Number: 019348960984. f. Model Number: DYNJ40632C, UPC Number: 019348946117. g. Model Number: DYNJ30141, UPC Number: 019348956435; Model Number: DYNJ34361, UPC Number 088438934847; Model Number: DYNJ42903B, UPC Number: 088827779801; Model Number: DYNJ43661B, UPC Number 088994280870; Model Number: DYNJ47226A, UPC Number: 088827756181; Model Number: DYNJ50624A, UPC Number 088994247463; Model Number: DYNJ51239A, UPC Number: 088994249354; Model Number: DYNJ58111C, UPC Number 019348984600; Model Number: DYNJ58126A, UPC Number: 019348948475; Model Number: DYNJ62299, UPC Number 019348964151; Model Number: DYNJ62544, UPC Number: 019348966652; Model Number: DYNJ65043A, UPC Number 019348937932; Model Number: DYNJ66398A, UPC Number: 019348941416; Model Number: DYNJ66398B, UPC Number 019348989192. h. Model Number: DYNJ60507A, UPC Number: 019348983055. i. Model Number: DYNJ0373279L, UPC Number: 019348956435; Model Number: DYNJ0373279M, UPC Number: 019348951902. j. Model Number: DYNJ46153A, UPC Number: 088994218586; Model Number: DYNJ46153B, UPC Number: 019348985364; Model Number: DYNJ52121, UPC Number: 088994224362. k. Model Number: DYNJ62742, UPC Number: 019348968592, Lot Numbers: 21LBP049, 22OBH570, 22EBP081, 22FBG069, 20XBB252, 21BBH070, 21DBJ756. l. Model Number: DYNJ36049, UPC Number: 019348956435. m. Model Number: DYNJ0149444M, UPC Number: 019348956435. n. Model Number: DYNJ45007, UPC Number: 088827708541; Model Number: DYNJ47004C, UPC Number: 019348969617; Model Number: DYNJ66244, UPC Number: 019348932371. o. Model Number: DYNJ33638K, UPC Number: 019348934328. p. Model Number: DYNJ49621B, UPC Number: 088994228223; Model Number: DYNJ63060A, UPC Number: 019348942308; Model Number: DYNJ63684F, UPC Number: 019348989720; Model Number: DYNJ68065, UPC Number: 019348947511; Model Number: DYNJ68065A, UPC Number: 019348988872; Model Number: DYNJT2344B, UPC Number: 088994210780. q. Model Number: DYNJ28067G, UPC Number: 088994274429; Model Number: DYNJVB1135A, UPC Number: 019348933993. r. Model Number: 00-401318L, UPC Number: 088827709176; Model Number: 00-401318M, UPC Number: 019348934875. s. Model Number: CDS984944C, UPC Number: 088994217295. t. Model Number: DYNJ44293D, UPC Number: 019348983341; Model Number: DYNJ47906, UPC Number: 088827752837; Model Number: DYNJ55252B, UPC Number: 019348987015; Model Number: DYNJ57498, UPC Number: 088994274574; Model Number: DYNJ65190C, UPC Number: 019348943311; Model Number: DYNJ66476, UPC Number: 019348935677; Model Number: DYNJC2371G, UPC Number: 088994249467. u. Model Number: DYNJ0854485T, UPC Number: 019348986419. v. Model Number: DYNJ43203F, UPC Number: 019348939286; Model Number: DYNJ64655A, UPC Number: 019348986331. w. Model Number: DYNJ65185, UPC Number: 019348925314. x. Model Number: DYNJ62379, UPC Number: 019348965170. y. Model Number: DYNJ41649F, UPC Number: 019348964127. z. Model Number: DYNJ42367A, UPC Number: 088827794377. aa. Model Number: DYNJ33457C, UPC Number: 019348946180. bb. Model Number: DYNJ68758, UPC Number: 019348983756. cc. Model Number: DYNJ63527, UPC Number: 019348974839. dd. Model Number: DYNJ62379, UPC Number: 019348965170. ee. Model Number: DYNJ19939M, UPC Number: 019348939324. ff. Model Number: DYNJ49931F, UPC Number: 019348947166. gg. Model Number: DYNJ906354C, UPC Number: 019348981670. hh. Model Number: DYNJ24225K, UPC Number: 088994251070. ii. Model Number: DYNJ61015B, UPC Number: 019348936888. jj. Model Number: DYNJ42499C, UPC Number: 019532703086. kk. Model Number: DYNJ57760B, UPC Number: 019348934258. ll. Model Number: DYNJ59465B, UPC Number: 019348947093. mm. Model Number: DYNJ0806254D, UPC Number: 088994247116. nn. Model Number: DYNJ37665B, UPC Number: 088994296973. oo. Model Number: WK100B, UPC Number: 019348934875. pp. Model Number: DYNJ49884B, UPC Number: 088994236366; Model Number: DYNJ49884F, UPC Number: 019348946957. qq. Model Number: DYNJ41553D, UPC Number: 088994281133. rr. Model Number: DYNJ60319A, UPC Number: 019348927629. ss. Model Number: DYNJ67245, UPC Number: 019348939305. tt. Model Number: DYNJ65482A, UPC Number: 019348941682. uu. Model Number: PHS41743D, UPC Number: 019348945327. vv. Model Number: DYNJ54755D, UPC Number: 019348943426; Model Number: DYNJ54755F, UPC Number: 019348988460. ww. Model Number: DYNJ60112, UPC Number: 088827779984. xx. Model Number: DYNJ57645A, UPC Number: 019348955794; Model Number: DYNJ57645B, UPC Number: 019348982865. yy. Model Number: DYNJ61747A, UPC Number: 019348971965. zz. Model Number: DYNJ64830, UPC Number: 019348922313. aaa. Model Number: DYNJ66500, UPC Number: 019348935791. bbb. Model Number: DYNJ0201109AG, UPC Number: 019348949726.

Why it was recalled

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Medline notified customers beginning on 05/15/2023, via mail and email with letter. Customers with Medline Probe Cover Kits were instructed to check inventory for affected kits, destroy any affected kits, and complete and return the response form. Distributors were instructed to notify their customers and have them document and destroy affected kits. Customers with the non-sterile and sterile procedural kits were instructed to quarantine kits, complete and return the response form and, once updated labels are received, over label and discard the affected ultrasound gel product within the kits. Distributors were instructed to notify customers of the recall and have customers return any affected product for return to Medline. Medline identified additional units of Medline Probe Cover Kits and notified customers on 06/22/2023. Customers were instructed to quarantine kits, complete and return the response form and, once updated labels are received, over label and discard the affected ultrasound gel product within the kits.

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

Timeline

Recall initiated: 2023-05-15
Posted by FDA: 2023-08-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #200962. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.