Centurion Surgical Hook Kits Recalled Due to Weak Seal
Medline Industries is recalling 1,520 Centurion surgical hook kits worldwide due to weak seals that may compromise sterility. The seal defect may not be detectable by users.
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 of sterile medical devices with potential for loss of sterility, representing a significant risk of harm. No illnesses or injuries have been reported, but compromised sterility in surgical instruments poses serious infection risk.
Plain-English summary
Medline Industries, LP is recalling 1,520 Centurion surgical hook kits marketed in four product variants: Sterile Skin Hook Fine (Product Code 66660), Sterile Small 2 Prong Skin Hook (Product Code 67105), Sterile NEWS Trach Hook (Product Code 67810), and Sterile Lillie Ear Hook Delicate 7" (Product Code I68655). These sterile surgical instruments have been distributed worldwide, including throughout the United States and to Panama and Canada.
The recalled kits contain a weak seal that may result in a breach of sterility. The seal weakness may not be detectable by users before the product is used, creating a risk that non-sterile instruments could be unknowingly deployed in surgical procedures.
Healthcare facilities and healthcare providers who have received these products should stop using them immediately and contact the manufacturer for guidance on replacement or return. Patients who may have undergone procedures using these instruments should consult with their healthcare provider.
The recalled product
- Product
- Centurion hook kits labeled as: a) STERILE SKIN HOOK FINE (EA3975F), Product Code 66660; b) STERILE SMALL 2 PRONG SKIN HOOK (25754), Product Code 67105; c) STERILE NEWS TRACH HOOK(83300), Product Code 67810; d) STERILE LILLIE EAR HOOK DELICATE 7", Product Code I68655
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 1,520
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) 66660
- UDI/DI 60653160052154 (case) 00653160052152 (each)
- Lot Numbers: 2023042790
- 2023091190
- b) 67105
- UDI/DI 60653160061880 (case) 00653160061888 (each)
- Lot Numbers: 2023042690
- c) 67810
- UDI/DI 30653160196703 (case) 00653160196702 (each)
- Lot Numbers: 2023060790
- 2023070790
- d) I68655
- UDI/DI 00653160317220 (case) 10653160317227 (each)
- Lot Numbers: 2023061290
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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