Medline Centurion surgical kits recalled due to weak seal
Medline Industries is recalling Centurion manual surgical kits because they may have weak seals that could compromise product sterility. The defect may not be noticeable to users before the kits are used.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for surgical kits with weak seals that could compromise sterility. No illnesses or injuries reported; the hazard is risk of patient harm if the sterile barrier fails. Per rubric, risk-of-harm products without reported injury score 3.
Plain-English summary
Medline Industries, LP is recalling four variants of Centurion manual surgical kits across the United States, Panama, and Canada. The recalled products include: Sterile Allis Tissue Forceps (Product Code I68905), Vaginal Repair Kit (Product Code MNS11505), PTCA Add-On Kit (Product Code MNS11545), and Instrument Set (Product Code SUT21355). A total of 1,335 units have been distributed.
The kits may have weak seals that could result in a breach of sterility of the contents if the seal fails during storage or handling. The weakness in the seal may not be detectable by users before the kit is opened and used.
Healthcare facilities and providers who received these surgical kits are affected by this recall. The kits were distributed to medical facilities across the United States and internationally.
Facilities should stop using affected kits and consult the recall notice for instructions on returning or destroying the product. Healthcare providers should verify whether they have received affected lots and take appropriate action.
The recalled product
- Product
- 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
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 1,335
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (14)
- a) I68905
- UDI/DI 00653160350944 (case) 10653160350941 (each)
- Lot Numbers: 2023012590
- 2023042590
- b) MNS11505
- UDI/DI 00653160320213 (case) 10653160320210 (each)
- Lot Numbers: 2023022490
- 2023071390
- c) MNS11545
- UDI/DI 00653160320305 (case) 10653160320302 (each)
- Lot Numbers: 2023021390
- d) SUT21355
- UDI/DI 00653160329223 (case) 10653160329220 (each)
- Lot Numbers: 2023060790
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 29 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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