Z-0648-2025 Class II Ongoing

Recalled by MEDLINE INDUSTRIES, LP - Northfield — Northfield, IL

Recall Details

Product Type
Devices
Report Date
December 11, 2024
Initiation Date
October 9, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1921 units

Product Description

MEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81, REF DYNJ27466S; 2) EYE PACK, REF DYNJ41207C; 3) CATARACT PACK, REF DYNJ43147G; 4) OSC OCULOPLASTIC PACK, REF DYNJ63329D; 5) OSC OCULOPLASTIC PACK, REF DYNJ63329F; 6) OCULAR PACK, REF DYNJ64138B; 7) OSC BREAST PACK, REF DYNJ65808C; 8) OCULOPLASTY PACK, REF DYNJ81798A; 9) OPHTHO PLASTIC, REF DYNJ902256C; 10) OCULAR, REF DYNJ909065; 11) OCULAR, REF DYNJ909065A; 12) PLASTIC EYE, REF DYNJVB91043A

Reason for Recall

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

Distribution Pattern

US Nationwide distribution.

Code Information

1) REF DYNJ27466S, UDI/DI 10195327350314 (each) 40195327350315 (case), Lot Numbers: 23DBA280; 2) REF DYNJ41207C, UDI/DI 10195327353063 (each) 40195327353064 (case), Lot Numbers: 23GMD059, 23KMH083; 3) REF DYNJ43147G, UDI/DI 10195327167257 (each) 40195327167258 (case), Lot Numbers: 22FBX412, 22FBS940; 4) REF DYNJ63329D, UDI/DI 10193489958065 (each) 40193489958066 (case), Lot Numbers: 22EBR487, 22EBC473; 5) REF DYNJ63329F, UDI/DI 10195327270414 (each) 40195327270415 (case), Lot Numbers: 23GMC980, 23LME454, 23IME156; 6) REF DYNJ64138B, UDI/DI 10193489355284 (each) 40193489355285 (case), Lot Numbers: 22FME241; 7) REF DYNJ65808C, UDI/DI 10195327369064 (each) 40195327369065 (case), Lot Numbers: 23KMF753, 23FMG930; 8) REF DYNJ81798A, UDI/DI 10195327515898 (each) 40195327515899 (case), Lot Numbers: 24CBM729, 24CBC467; 9) REF DYNJ902256C, UDI/DI 10195327089368 (each) 40195327089369 (case), Lot Numbers: 22FDA445, 22HDA810, 23CDB064, 23HDB222, 23IDB778, 23FDB836; 10) REF DYNJ909065, UDI/DI 10195327260019 (each) 40195327260010 (case), Lot Numbers: 23CMB048, 23CMA495; 11) REF DYNJ909065A, UDI/DI 10195327460648 (each) 40195327460649 (case), Lot Numbers: 24IME711, 24HME507; 12) REF DYNJVB91043A, UDI/DI 10195327309541 (each) 40195327309542 (case), Lot Numbers: 22LDB968, 23JDC086, 23KDB345, 23FDA062, 24DDB815, 24FDB470