—#205665

Product

Medline Kits, trays, and packs labeled as follows: a) CATARACT PACK, REF VAL011CTASD; b) CATARACT PACK, REF DYNJ68875F; c) CATARACT PACK, REF DYNJ54869F; d) CATARACT PREP PACK, REF DYNJ44917L; e) E-BLEPH CDS, REF CDS983585G; f) EYE CDS, REF CDS983916G; g) EYE KIT, REF DYKM2222; h) EYE PLASTIC PACK, REF DYNJ47859C; i) K PACK, REF LYN030KAGVD; j) OCULOPLASTY PACK, REF DYNJ64572A; k) OL OCULAR, REF DYNJ906183J; l) OL OCULAR, REF DYNJ906183K; m) P M CATARACT, REF DYNJ44917G; n) P M CATARACT, REF DYNJ44917I; o) P PACK, REF LYN030POGVD; p) R VITRECTOMY, REF EYP087W; q) VITRECTOMY PACK, REF DYNJ68884B

FDA product code: OJK — Eye Tray
Device class: Class 2
Medical specialty: Ophthalmic
Affected lot / code info: a) REF VAL011CTASD, UDI/DI 40195327152032 (case), 10195327152031 (unit), Lot Numbers: 22LBB812, 22LBH455; b) REF DYNJ68875F, UDI/DI 40195327382125 (case), 10195327382124 (unit), Lot Numbers: 23FBQ273, 23GBS122, 23GBS486, 23HBP752; c) REF DYNJ54869F, UDI/DI 40195327407286 (case), 10195327407285 (unit), Lot Numbers: 23FBQ273, 23GBS122, 23GBS486, 23HBP752; d) REF DYNJ44917L, UDI/DI 40195327472604 (case), 10195327472603 (unit), Lot Numbers: 23HBS811; e) REF CDS983585G, UDI/DI 40193489460781 (case), 10193489460780 (unit), Lot Numbers: 22DBI589, 22HBA111, 22JBQ351, 23EBG770; f) REF CDS983916G, UDI/DI 40193489803861 (case), 10193489803860 (unit), Lot Numbers: 22CBV428, 22GBP859, 22HBP383, 23EBP259, 23GBG620, 23IBS207, 23JBW354; g) REF DYKM2222, UDI/DI 40195327337255 (case), 10195327337254 (unit), Lot Numbers: 23DBI071; h) REF DYNJ47859C, UDI/DI 40193489916066 (case), 10193489916065 (unit), Lot Numbers: 23EBA347; i) REF LYN030KAGVD, UDI/DI 40193489956574 (case), 10193489956573 (unit), Lot Numbers: 22ABH632, 22ABW357, 22CBL660, 22IBS624; j) REF DYNJ64572A, UDI/DI 40195327112555 (case), 10195327112554 (unit), Lot Numbers: 22GBL794; k) REF DYNJ906183J, UDI/DI 40195327279449 (case), 10195327279448 (unit), Lot Numbers: 22LMC016, 22LMH698, 23AME088, 23AMF669, 23BMH365, 23CMB182, 23EMA555; l) REF DYNJ906183K, UDI/DI 40195327385522 (case), 10195327385521 (unit), Lot Numbers: 23FMC104, 23FME336, 23GMD288, 23HMH680; m) REF DYNJ44917G, UDI/DI 40195327031481 (case), 10195327031480 (unit), Lot Numbers: 22BBV644; n) REF DYNJ44917I, UDI/DI 40195327156375 (case), 10195327156374 (unit), Lot Numbers: 22FBN595, 22IBK002; o) REF LYN030POGVD, UDI/DI 22ABM649, 22ABW358, 22BBK347, 22CBT855, 22EBR210, 22HBR247, 22KBH816, 22LBA956, 22OBF733, 23ABB019, 23BBQ119; p) REF EYP087W, UDI/DI 50653160050221 (case), 00653160050226 (unit), Lot Numbers: 40195327037254 (case), 10195327037253 (unit), Lot Numbers: 22CBF187, 22EBE045, 22FBO783, 22GBZ358, 22IBF001, 22JBC220, 22KBN864, 22OBE478, 23ABG110, 23BBR173, 23DBH202; q) REF DYNJ68884B, UDI/DI 40195327059010 (case), 10195327059019 (unit), Lot Numbers: 22GBG399

Why it was recalled

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

MEDLINE issued an IMMEDIATE ACTION REQUIRED NURSE ASSIST PRODUCT RECALL notice to its consignees on 11/16/2023 via USPS first class mail and email. The notice explained the problem, requested log on to their portal to identify the products and check their inventory so the product could be quarantined. Once Medline receives the completed response form, over-labels will be shipped to the consignee. Medline Industries, LP instructed customers to over-label the convenience kits with a warning label indicating to remove the sodium chloride irrigation or Sterile water and replace from a different sterile supply. Distributors or consignees who further distributed the affected products were directed to notify their customers. For questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.

Recalling firm

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

Distribution

Distribution pattern: Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama

Timeline

Recall initiated: 2023-11-15
Posted by FDA: 2024-02-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #205665. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.