Sterile Cover Surgical Device Recalled for Risk of Elastic Band Detachment
Lumicell's sterile surgical covers are being recalled because elastic bands may detach or fracture during surgery, potentially leaving foreign bodies in the surgical site and causing infection. The recall affects 200 units in CA, FL, MA, NC, and TX.
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 recall is classified as High (score 3) because it involves a risk-of-harm medical device where elastic band detachment could result in retained foreign bodies and surgical site infections, but no illnesses or injuries have been reported in the source text. FDA Class II recalls with theoretical risk to patient safety, absent actual injuries, warrant this score.
Plain-English summary
Lumicell, Inc. is recalling 200 units of its 900-00218 Sterile Cover used in the Lumicell Direct Visualization System. The recall was initiated due to the potential of elastic bands included in the sterile cover kit to detach or fracture during surgical procedures.
When these elastic bands fail, they may remain in the surgical cavity as retained foreign bodies. This poses a risk of surgical site infections, which can lead to serious complications requiring additional medical intervention.
Affected lots include: 43930, 43931, 43932, 43933, 42756, 44349, 44349-01, 44349-02, 44349-03, and 44349-04. The recalled products were distributed in California, Florida, Massachusetts, North Carolina, and Texas.
Healthcare providers using affected sterile covers should discontinue use and contact Lumicell, Inc. for further instructions. Patients who may have been affected should consult with their healthcare provider if they experience symptoms of surgical site infection such as increased pain, redness, swelling, or discharge at the incision site.
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
- retained-foreign-body
- surgical-site-infection
- device-failure
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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