Recall Z-1442-2024— MEDLINE INDUSTRIES, LP - Northfield
Class II · Ongoing
Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2024-02-23. FDA's recall record names no specific 510(k) clearance for this event. Product: Centurion manual surgical kits labeled as: a) ST. VIRTUS SPLINTER FORCEP 6" (SF8246), Product Code 66580; b) DEBRIDEMENT TRAY, Product Code I86630; c) BIOPSY INSTRUMENT PACK, Product Code I86690; d) DEBRIDEMENT TRAY, Product Code I86815; e) IR ADSON FORCEP & NEEDLE HOLDER, Product Code MNS12675; f) TOENAIL REMOVAL KIT, Product Code SUT20350 MEDLINE GENERAL PURPOSE INST. TRAY, Product Code DYNDA2346A. Reason: Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users..
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-02-23
- Firm location
- Northfield, IL, United States
Product description
Centurion manual surgical kits labeled as: a) ST. VIRTUS SPLINTER FORCEP 6" (SF8246), Product Code 66580; b) DEBRIDEMENT TRAY, Product Code I86630; c) BIOPSY INSTRUMENT PACK, Product Code I86690; d) DEBRIDEMENT TRAY, Product Code I86815; e) IR ADSON FORCEP & NEEDLE HOLDER, Product Code MNS12675; f) TOENAIL REMOVAL KIT, Product Code SUT20350 MEDLINE GENERAL PURPOSE INST. TRAY, Product Code DYNDA2346A
Reason for recall
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
Data sourced from openFDA. This site is unofficial and independent of the FDA.