Centurion Sterile Weitlaner Retractor recalled for sterile packaging puncture risk
Medline Industries is recalling Centurion Sterile Weitlaner Retractor 3 x 4 Prong units because the retractors may puncture through the sterile packaging. The product is distributed nationwide.
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 medical device recall where compromised sterile packaging creates a risk of harm to patients (potential contamination or infection); no illnesses or injuries are reported, so the severity is capped at High per the rubric.
Plain-English summary
Medline Industries, LP is recalling the Centurion Sterile Weitlaner Retractor 3 x 4 Prong (Reorder: I68395) due to a potential for the retractors to puncture through the sterile packaging. This recall affects 840 units distributed nationwide.
The affected units include 16 lot numbers: 2020061990, 2020070990, 2020110490, 2020111090, 2021082590, 2021121490, 2022062890, 2022110190, 2022121990, 2023032290, 2023032390, 2023092590, 2024050790, 2024053090, 2024062490, and 2024070190. The UDI/DI and case identifiers are 10653160287018 (each) and 00653160287011 (case).
If you possess an affected unit, discontinue use and contact Medline Industries for further instructions.
The recalled product
- Product
- Centurion Sterile Weitlaner Retractor 3 x 4 Prong, Reorder: I68395
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 840
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 (17)
- UDI/DI 10653160287018 (each) 00653160287011 (case)
- Lot Numbers: 2020061990
- 2020070990
- 2020110490
- 2020111090
- 2021082590
- 2021121490
- 2022062890
- 2022110190
- 2022121990
- 2023032290
- 2023032390
- 2023092590
- 2024050790
- 2024053090
- 2024062490
- 2024070190.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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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