Z-0641-2025Class II
MEDLINE convenience kits labeled as: 1) VAGINAL, REF CDS984955M; 2) DAY SURG LARGE VAG CDS, REF CDS984995M...
MEDLINE INDUSTRIES, LP - Northfield / initiated 2024-10-09 / Open, Classified / root cause: manufacturing process
MEDLINE INDUSTRIES, LP - Northfield began a recall of 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)... on . FDA classified it as Class II and gives the reason as "Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-0641-2025
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- 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
- Product code
- MLS Labor And Delivery Kit
- Reason for recall
- Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
- Root cause tag
- manufacturing process
- FDA root cause
- Under Investigation by firm
- Action
- 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.
- Quantity in commerce
- 1952 units
- Distribution
- US Nationwide distribution.
- Product codes and lots
- 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
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0622-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0623-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0624-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0625-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0626-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0627-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0628-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0629-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0630-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0631-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0632-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0633-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0634-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0635-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0636-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0637-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0638-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0639-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0640-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0641-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0642-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0643-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0644-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0645-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0646-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0647-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0648-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0649-2025 | Class II | Ongoing | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.