MEDLINE convenience kits labeled as: 1) VAGINAL, REF CDS984955M; 2) DAY SURG LARGE VAG CDS, REF CDS984995M; 3) MA
Summary
The FDA issued a Class II for MEDLINE convenience kits labeled as: 1) VAGINAL, REF CDS984955M; 2) DAY SUR by MEDLINE INDUSTRIES, LP - Northfield. Reason: Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryke.
Details
Source
Device Recall
External ID
Z-0641-2025
Action Date
2024-12-11
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: 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
Quantity Affected: 1952 units
Reason for Recall
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-10-09
Company
Northfield, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 225 device recalls issued in the same week, part of 413 device-related FDA actions this month.
MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (MEDLINE INDUSTRIES, LP - Northfield) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does MEDLINE INDUSTRIES, LP - Northfield have FDA actions?
MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0641-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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