Customed Recalls Basic Pack 1 Surgical Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling Basic Pack 1 surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of 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 product (loss of sterility/contamination) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Customed, Inc. is recalling Basic Pack 1 (Ill) surgical packs, which contain table covers, drapes, towels, suture bags, and sheets. The recall involves 5 lots totaling 1,110 units. The affected product is EO sterilized and packaged in polyester/polyethylene breather bags with Tyvek double vents.
The recall was initiated because Customed determined that packaging integrity may be compromised on different catalog numbers. This defect could result in an injury to the patient due to product contamination or the loss of the product's sterility condition.
The affected products were distributed worldwide, including nationwide in the United States (specifically Florida, Puerto Rico, and the US Virgin Islands) and in the countries of Tortola, Trinidad, Dominican Republic, Costa Rica, and Mexico. Consumers and healthcare facilities should stop using the affected lots and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- BASIC PACK 1 (Ill) CUSTOMED CONTENTS: (1) TABLE COVER REINFORCED 44" X 78" (4) DRAPE UTILITY WffAPE (2) TOWELS ABSORBENT 15" X 20" (1) SUTURE BAG FLORAL (1) DRAPE SHEET 42" X 57" SMS (1) SHEET :X 57" X 63" REINFORCED SMS (1) MAYO STAND COVER REINFORCED Product Usage: E
- 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 (2)
- Product code 900-2471
- 5 lots 112041034 112051959 112072723 113078521 140513219
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.
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