Customed Recalls Lithotomy Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 2,675 units of Lithotomy Packs across 29 lots due to potential packaging integrity issues that could compromise 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: The recall involves a risk of harm (injury due to contamination or loss of sterility) for a medical device, but the source text does not report any actual illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Customed, Inc. has initiated a recall of 2,675 units of Lithotomy Packs, comprising 29 distinct lots. The recall is due to a determination that packaging integrity may be compromised on different catalog numbers. The affected products are EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bags with Tyvek double vents.
The potential compromise in packaging integrity could result in product contamination or a loss of sterility condition, which poses a risk of injury to patients. The recall covers products distributed worldwide, including the United States (nationwide, specifically Florida, Puerto Rico, and the US Virgin Islands) and international locations such as Tortola, Trinidad, the Dominican Republic, Costa Rica, and Mexico.
Healthcare facilities and consumers who have these specific lots should stop using the products and contact Customed, Inc. for instructions on return or replacement. The affected product code is 900-2167, and the specific lot numbers are listed in the official recall documentation.
The recalled product
- Product
- LITHOTOMY PACK CONTENTS: (2) TOWELS ABSORBENT 15" X 20" (2) LEGGINGS W/7'' CUFF 30" X 42" CSR (1) DRAPE UNDERBUTTOCK WITH POUCH 44" x 35" (1) DRAPE ABDOMINAL WITH TAPE 40" X 54" (1) DRAPE UTILITY WITH TAPE (1) TABLE COVER REINFORCED 50" X 90" (1) TIME OUT BEACON NON
- Manufacturer
- Customed, Inc
- Category
- Medical Device — Surgical Packs
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 (1)
- Product code 900-2167
Distribution
Part of a larger recall action
This product is one of 233 recalled by Customed, Inc 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.
See all 233 products in this recall →Related recalls
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