Medline Centurion Sterile Weitlaner Retractor Recalled Due to Packaging Defect
Medline is recalling 840 units of Centurion Sterile Weitlaner Retractors because the sterile packaging could be punctured, potentially compromising device sterility.
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: This is a Class II medical device with an identified packaging defect that could compromise sterility. While no injuries or illnesses have been reported, the product is a risk-of-harm item—contamination of a surgical retractor could introduce infection at a surgical site.
Plain-English summary
Medline Industries, LP is recalling 840 units of Centurion Sterile Weitlaner Retractor 3 x 4 Prong distributed nationwide in the United States.
The recall is due to a potential defect in the retractors' sterile packaging that could allow puncturing. If the sterile packaging is compromised, the device may no longer be sterile.
The affected lot numbers are: 2020061990, 2020070990, 2020110490, 2020111090, 2021082590, 2021121490, 2022062890, 2022110190, 2022121990, 2023032290, 2023032390, 2023092590, 2024050790, 2024053090, 2024062490, and 2024070190.
The recalled product
- Product
- Centurion Sterile Weitlaner Retractor 3 x 4 Prong, Reorder: I68395
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- sterile-packaging-defect
- 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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