Centurion manual surgical kits labeled as: a) STERILE ALLIS TISS FCP 10", Product Code I68905; b) VAGINAL REPAIR KIT, Product Code MNS11505; c) PTCA ADD-ON KIT, Product Code MNS11545; d) INSTRUMENT SET, Product Code SUT21355
Reported: April 10, 2024 Initiated: February 23, 2024 #Z-1443-2024
Product Description
Centurion manual surgical kits labeled as: a) STERILE ALLIS TISS FCP 10", Product Code I68905; b) VAGINAL REPAIR KIT, Product Code MNS11505; c) PTCA ADD-ON KIT, Product Code MNS11545; d) INSTRUMENT SET, Product Code SUT21355
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.
Details
- Recalling Firm
- MEDLINE INDUSTRIES, LP - Northfield
- Units Affected
- 1335 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Panama, Canada.
- Location
- Northfield, IL
Frequently Asked Questions
What product was recalled? ▼
Centurion manual surgical kits labeled as: a) STERILE ALLIS TISS FCP 10", Product Code I68905; b) VAGINAL REPAIR KIT, Product Code MNS11505; c) PTCA ADD-ON KIT, Product Code MNS11545; d) INSTRUMENT SET, Product Code SUT21355. Recalled by MEDLINE INDUSTRIES, LP - Northfield. Units affected: 1335 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 10, 2024. Severity: Moderate. Recall number: Z-1443-2024.
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