—#210813

Product

MEDLINE convenience kits labeled as: 1) MAJOR LITHOTOMY CDS-LF, REF CDS760056G; 2) LAVH CDS, REF CDS983411J; 3) MAJOR VAGINAL, REF CDS983497L; 4) DAY SURG LARGE VAG CDS, REF CDS984995N; 5) GYN LAPAROTOMY HARPER PACK-LF, REF DYNJ0160684F; 6) D&C/HYSTEROSCOPY PACK, REF DYNJ01921M; 7) HYSTERECTOMY PACK-LF, REF DYNJ0488471K; 8) VAG HYST PACK-LF, REF DYNJ0532873M; 9) VAG HYST PACK-LF, REF DYNJ0532873N; 10) VAGINAL PROCEDURES PACK-LF, REF DYNJ0750737Q; 11) MINOR VAGINAL #76-RF, REF DYNJ27434R; 12) DB VAG HYSTERECTOMY-LF, REF DYNJ33590I; 13) VAG HYST PACK, REF DYNJ36628L; 14) VAG HYST PACK, REF DYNJ36628M; 15) ROBOTIC HYSTO URO PACK, REF DYNJ40623F; 16) ABDOMINAL HYST PACK, REF DYNJ44848L; 17) DA VINCI HYSTERECTOMY, REF DYNJ44863Q; 18) VAGINAL HYSTERECTOMY PACK, REF DYNJ44900O; 19) VAGINAL HYSTERECTOMY PACK, REF DYNJ44900P; 20) URO GYN, REF DYNJ50047G; 21) LAVH NEW BRAUNFELS, REF DYNJ61136D; 22) ABDOMINAL PERINEAL, REF DYNJ63371D; 23) ABDOMINAL HYST FFX, REF DYNJ63631A; 24) VAGINAL HYSTERECTOMY PACK, REF DYNJ67194B; 25) LAVH PACK, REF DYNJ67210A; 26) VAG MINOR PACK, REF DYNJ82216; 27) VAG MINOR PACK, REF DYNJ82216B; 28) ABDOMINAL HYSTERECTOMY, REF DYNJ900091F; 29) VAGINAL, REF DYNJ900292K; 30) GYN LAPAROTOMY, REF DYNJ900296J; 31) LAVH, REF DYNJ900298J; 32) LAVH, REF DYNJ900298K; 33) LITHOTOMY-LF, REF DYNJ900721C; 34) MAJOR VAGINAL-LF, REF DYNJ901807I; 35) ABDOMINAL HYSTERECTOMY, REF DYNJ906478F; 36) VAGINAL HYST, REF DYNJ907220A; 37) PRENTICE GYNE ONCOLOGY KIT, REF DYNJ908792; 38) PRENTICE TOTAL ABD HYST KIT, REF DYNJ908795; 39) PRENTICE TOTAL ABD HYST KIT, REF DYNJ908795B; 40) PRENTICE VAG HYST KIT, REF DYNJ908796; 41) PRENTICE VAG HYST KIT, REF DYNJ908796B; 42) KIT LAVH CENTRAL DUPAGE, REF DYNJ908825; 43) KIT PFANNENSTIEL GYN, REF DYNJ908826; 44) KIT VAGINAL HYSTERECTOMY, REF DYNJ908837

FDA product code: OJF — Hysterectomy Kit
Device class: Class 2
Medical specialty: Obstetrics/Gynecology
Affected lot / code info: 85OJF 1) REF CDS760056G, UDI/DI 10195327009656 (each) 40195327009657 (case), Lot Numbers: 24BBQ489, 23KBP697; 2) REF CDS983411J, UDI/DI 10195327150273 (each) 40195327150274 (case), Lot Numbers: 22LDA249, 23CDB670, 23JDA480, 23IDA660; 3) REF CDS983497L, UDI/DI 10195327560980 (each) 40195327560981 (case), Lot Numbers: 24ADA431, 24BDB524; 4) REF CDS984995N, UDI/DI 10195327587963 (each) 40195327587964 (case), Lot Numbers: 24GBH834, 24EBL666, 24ABA667, 24DBI833, 24CBU970, 24CBJ697; 5) REF DYNJ0160684F, UDI/DI 10195327304287 (each) 40195327304288 (case), Lot Numbers: 22LDB323, 22LDC130, 23CDA546; 6) REF DYNJ01921M, UDI/DI 10195327491673 (each) 40195327491674 (case), Lot Numbers: 23IBT540; 7) REF DYNJ0488471K, UDI/DI 10195327046064 (each) 40195327046065 (case), Lot Numbers: 22EBG378, 23CBQ258, 23CBA485, 23KBC614, 23HBP501, 23JBT064, 23IBV599; 8) REF DYNJ0532873M, UDI/DI 10195327083465 (each) 40195327083466 (case), Lot Numbers: 22FMH645, 22HMF692; 9) REF DYNJ0532873N, UDI/DI 10195327249694 (each) 40195327249695 (case), Lot Numbers: 23DMD053; 10) REF DYNJ0750737Q, UDI/DI 10195327196783 (each) 40195327196784 (case), Lot Numbers: 23FMC422; 11) REF DYNJ27434R, UDI/DI 10195327107727 (each) 40195327107728 (case), Lot Numbers: 22EBR089, 23ABM013, 23CBX286; 12) REF DYNJ33590I, UDI/DI 10195327469542 (each) 40195327469543 (case), Lot Numbers: 23JDA425, 23GDB694, 23JDA783; 13) REF DYNJ36628L, UDI/DI 10193489437188 (each) 40193489437189 (case), Lot Numbers: 22HMF864, 23EMB913; 14) REF DYNJ36628M, UDI/DI 10195327437268 (each) 40195327437269 (case), Lot Numbers: 23LMC975, 23LMC305, 24AMC175, 23FMD871; 15) REF DYNJ40623F, UDI/DI 10195327435783 (each) 40195327435784 (case), Lot Numbers: 23IBR215; 16) REF DYNJ44848L, UDI/DI 10195327127565 (each) 40195327127566 (case), Lot Numbers: 22IDA312, 22LDB966; 17) REF DYNJ44863Q, UDI/DI 10195327298227 (each) 40195327298228 (case), Lot Numbers: 23ADA450, 23CDC113, 23CDA613, 23BDA189; 18) REF DYNJ44900O, UDI/DI 10195327127770 (each) 40195327127771 (case), Lot Numbers: 22HDB535, 22KDB315; 19) REF DYNJ44900P, UDI/DI 10195327298548 (each) 40195327298549 (case), Lot Numbers: 22KDB784, 22LDA872, 22LDB908, 23DDA086; 20) REF DYNJ50047G, UDI/DI 10195327107734 (each) 40195327107735 (case), Lot Numbers: 22FBN014, 22LBP709, 23DBJ770, 23CBF613; 21) REF DYNJ61136D, UDI/DI 10195327470302 (each) 40195327470303 (case), Lot Numbers: 23IBN858; 22) REF DYNJ63371D, UDI/DI 10193489983784 (each) 40193489983785 (case), Lot Numbers: 22DBL296, 22FBS033; 23) REF DYNJ63631A, UDI/DI 10193489900309 (each) 40193489900300 (case), Lot Numbers: 22HBC445, 22FBR617, 22LBD142, 23BBQ558, 23GBC822, 23GBT620, 23JBL757; 24) REF DYNJ67194B, UDI/DI 10195327299699 (each) 40195327299690 (case), Lot Numbers: 23ABQ738; 25) REF DYNJ67210A, UDI/DI 10195327150532 (each) 40195327150533 (case), Lot Numbers: 22GBY195, 22GBO568; 26) REF DYNJ82216, UDI/DI 10195327183769 (each) 40195327183760 (case), Lot Numbers: 23HMI516; 27) REF DYNJ82216B, UDI/DI 10195327534820 (each) 40195327534821 (case), Lot Numbers: 23JMG567; 28) REF DYNJ900091F, UDI/DI 10195327075613 (each) 40195327075614 (case), Lot Numbers: 23ABM839, 23HBA598, 23JBR356, 23HBV298, 23IBP601; 29) REF DYNJ900292K, UDI/DI 10193489915730 (each) 40193489915731 (case), Lot Numbers: 22GBK158, 22FBL459, 23DBA365, 22LBH130, 22LBC401, 23EBT068; 30) REF DYNJ900296J, UDI/DI 10193489915754 (each) 40193489915755 (case), Lot Numbers: 22GBT650, 23DBA294, 23EBG706; 31) REF DYNJ900298J, UDI/DI 10193489915167 (each) 40193489915168 (case), Lot Numbers: 22EBB287, 22DBT480, 23DBD352, 22LBC402, 22KBW389; 32) REF DYNJ900298K, UDI/DI 10195327373337 (each) 40195327373338 (case), Lot Numbers: 23GBM311; 33) REF DYNJ900721C, UDI/DI 10193489951608 (each) 40193489951609 (case), Lot Numbers: 22EBO945, 22HBE990, 23ABQ354, 22LBE624, 22KBC673, 23EBV945; 34) REF DYNJ901807I, UDI/DI 10195327496166 (each) 40195327496167 (case), Lot Numbers: 23KDB594, 23IDC225, 24CDB873, 24BDB761; 35) REF DYNJ906478F, UDI/DI 10195327202675 (each) 40195327202676 (case), Lot Numbers: 23GDB463, 23IDB304; 36) REF DYNJ907220A, UDI/DI 10195327329648 (each) 40195327329649 (case), Lot Numbers: 23BME638; 37) REF DYNJ908792, UDI/DI 10195327183264 (each) 40195327183265 (case), Lot Numbers: 23CDA683; 38) REF DYNJ908795, UDI/DI 10195327183288 (each) 40195327183289 (case), Lot Numbers: 23DDB794, 23FDB261, 23JDB336; 39) REF DYNJ908795B, UDI/DI 10195327535049 (each) 40195327535040 (case), Lot Numbers: 24AMA320, 24BMK237, 24AMH044; 40) REF DYNJ908796, UDI/DI 10195327183271 (each) 40195327183272 (case), Lot Numbers: 23IDA364, 23EDA172; 41) REF DYNJ908796B, UDI/DI 10195327535056 (each) 40195327535057 (case), Lot Numbers: 23LMF165; 42) REF DYNJ908825, UDI/DI 10195327185121 (each) 40195327185122 (case), Lot Numbers: 23BDA825, 23EDC464; 43) REF DYNJ908826, UDI/DI 10195327185145 (each) 40195327185146 (case), Lot Numbers: 22LDA975; 44) REF DYNJ908837, UDI/DI 10195327185169 (each) 40195327185160 (case), Lot Numbers: 23IDB086, 23JDA593, 23HDB464, 23HDB110

Why it was recalled

Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Medline issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 10/11/2024 via mail and email. The notice explained the problem with the Stryker component, potential risk, requested the kits be quarantined pending additional labeling and o respond through their portal: https://recalls.medline.com. Once the response is received, Medline will provide additional labeling to be applied to the affected kits which states the following: "Attention: R-24-219, This kit contains a recalled item, STRYKER SafeAir Smoke Evacuation Pencil, VPN: 0703-047-000, 0703-047-001, 0703-047-002, 0703-046-000, 0703-046-001, 0703-046-002. DO NOT USE THIS COMPONENT. The rest of the kit may be used. Please remove this item only and replace with product from supply. *Do not cover or remove this sticker*". Those further distributing the product were directed to notify their customers.

Recalling firm

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

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2024-10-09
Posted by FDA: 2024-12-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #210813. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.