Recall Z-0756-2025
MEDLINE INDUSTRIES, LP - Northfield · initiated November 12, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
ST OR MAYO HEGAR NEEDLEHOLDER 6"(OR2500), Medline Item No. 67870
Codes / lots: UDI: 00653160196894 (ea) 30653160196895 (case); Lot 2023091290
Reason for recall
Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
FDA-determined cause: Process control
Action taken
On November 25, 2024, the firm notified customers via letters titled IMMEDIATE ACTION REQUIRED. Customers were informed that specific items and lots of Pure Pouch Single-Sterile and Sterile Kits are being recalled due to weak seals. Affected product must be destroyed. The letter included instructions on actions to take to be issued a credit. Customers should immediately check their stock for affected product and quarantine all units. Affected lots should be destroyed. When the recalling firm has received your completed destruction form, your account will be issued a credit, if applicable. If you have any questions, please contact 866-359-1704.
Details
- Recall number
- Z-0756-2025
- Initiated
- November 12, 2024
- Posted by FDA
- December 23, 2024
- Product code
- GEN – Forceps, General & Plastic Surgery
- Quantity
- 21,440 total
- Distribution
- US Nationwide distribution.
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0754-2025 Class II | STERILE STRT KELLY HEMOSTAT (SK8039S), Medline Item No. 66695Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to… | 11/12/2024Open, Classified |
| Z-0755-2025 Class II | O.R. SCISSORS, S/B, 5.5 STERILE, Medline Item No. DYND04000Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to… | 11/12/2024Open, Classified |
| Z-0757-2025 Class II | STERILE MAGILL FORCEP (MAGF9), Medline Item No. 66790Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to… | 11/12/2024Open, Classified |
| Z-0758-2025 Class II | ST REPROCESSED BRUNS CURETTE #00 (BC00), Medline Item No. 67600KWeak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to… | 11/12/2024Open, Classified |
| Z-0759-2025 Class II | ST IUD REMOVAL HOOK 10" (504090), Medline Item No. I68785Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to… | 11/12/2024Open, Classified |
| Z-0760-2025 Class II | RUMMELL, Medline Item No. ST006STWeak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to… | 11/12/2024Open, Classified |