Recall Z-1449-2024— 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) STERILE S/B WIRE SCISSOR, Product Code 65140; b) SHARP/SHARP SCISSORS 41/2", Product Code 65840; c) STERILE WIRE CUTTER (WCS144), Product Code 66240; d) STERILE LISTER BANDAGE SCISSOR (LS122), Product Code 66855; e) STERILE UTILITY SHEARS (USH176), Product Code 67225; f) STERILE ANGLED BANDAGE SCISSOR (LIST55), Product Code TRI66670. 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) STERILE S/B WIRE SCISSOR, Product Code 65140; b) SHARP/SHARP SCISSORS 41/2", Product Code 65840; c) STERILE WIRE CUTTER (WCS144), Product Code 66240; d) STERILE LISTER BANDAGE SCISSOR (LS122), Product Code 66855; e) STERILE UTILITY SHEARS (USH176), Product Code 67225; f) STERILE ANGLED BANDAGE SCISSOR (LIST55), Product Code TRI66670
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.