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Recall Observatory FDA recall evidence

Device product

MEDLINE convenience kits labeled as: 1) VAGINAL, REF CDS984955M; 2) DAY SURG LARGE VAG CDS, REF CDS984995M; 3) MAJOR VAGINAL PACK-LF, REF DYNJ0826768P; 4) VAGINAL PACK, REF DYNJ59081C; 5)VAGINOPLASTY PACK, REF DYNJ65807C; 6) ACH MAJOR VAGINAL PACK, REF DYNJ67757B

Z-0641-2025

October 09, 2024

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 95621
Status
Ongoing
Classification
Class II
Quantity
1952 units
Official record key
device-enforcement:Z-0641-2025

Official wording

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

Code information: 1) REF CDS984955M, UDI/DI 10195327313302 (each) 40195327313303 (case), Lot Numbers: 23CBU078, 23HBG687, 23IBF280; 2) REF CDS984995M, UDI/DI 10195327043766 (each) 40195327043767 (case), Lot Numbers: 22GBA249, 23ABF616, 23ABF770, 23EBG938, 23CBD779, 23GBH707, 23KBU446, 23IBE467; 3) REF DYNJ0826768P, UDI/DI 10193489265699 (each) 40193489265690 (case), Lot Numbers: 22FMC589, 22DMI812, 23AMG530, 23FMI241, 23HMI199, 23JMF359; 4) REF DYNJ59081C, UDI/DI 10195327200404 (each) 40195327200405 (case), Lot Numbers: 22HBC733, 22LBL495, 23CBU862, 23BBF607, 23FBI028, 23EBU222, 23BBS154, 23GBI132, 23KBA604, 23JBE732; 5) REF DYNJ65807C, UDI/DI 10195327273668 (each) 40195327273669 (case), Lot Numbers: 23AMH550, 23DMD460, 23IMG365; 6) REF DYNJ67757B, UDI/DI 10195327228002 (each) 40195327228003 (case), Lot Numbers: 22HBH633, 22KBS878, 22JBF053, 23CBC829, 23BBH334

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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

Field note

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