Sterile cover kits recalled because elastic bands may detach during surgery
Sterile Cover 10-Pack Shipper Box Assemblies are recalled because elastic bands in the kit may detach or fracture during surgery, risking retained foreign bodies and surgical site infection. 200 units are affected.
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; the notice describes possible retained foreign bodies and surgical site infection, with no injuries reported.
Plain-English summary
The 900-00218 Sterile Cover 10-Pack Shipper Box Assembly, model and catalog number 900-00218, is being recalled. The recall covers 200 units, supplied as 20 packs of 10, distributed in California, Florida, Massachusetts, North Carolina and Texas.
The recall was issued because of the potential for the elastic bands included in the kit to detach or fracture during surgical procedures. The manufacturer states these failures may pose a risk of retained foreign bodies in the surgical cavity, potentially leading to surgical site infections. The FDA classified the action as Class II.
Hospitals and surgical centres holding affected packs should quarantine them and follow the manufacturer's instructions for return or replacement.
The recalled product
- Product
- Brand Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Product Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Model/Catalog Number: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Software Version: Not Applicable Product Description: Sterile Cover
- Manufacturer
- Lumicell, Inc.
- Hazard
- component-failure
- retained-foreign-body
- infection-risk
- class-ii
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)
- 840-00204 Assy
- Dispenser Carton Sterile Cover: (01)0 0860003 25251 2
- 810-00210 Assy
- Outer Tray Sterile Cover: (01) 0 0860003 2520 5
- Lot numbers: 43930
- 43931
- 43932
- 43933
- 42756
- 44349
- 44349-01
- 44349-02
- 44349-03
- 44349-04
Distribution
Distributed nationwide across the United States.
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