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.
What this means for you
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
- Hazard
- sterile-packaging-breach
- contamination-risk
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.
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