Customed Recalls EENT Surgical Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling EENT surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly identifies the agency classification as Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Customed, Inc. is recalling EENT Pack I surgical packs due to a potential compromise in packaging integrity. The affected products are EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bags with Tyvek double vents. The recall involves 4 lots totaling 700 units, with product code 900-2498 and specific lot numbers 112020356, 112051968, 112072870, and 113078527.
The recall was initiated because the compromised packaging could result in product contamination or a loss of sterility condition, which poses a risk of injury to patients. The agency has classified this as a Class I recall.
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. Healthcare facilities and consumers should stop using these products and contact the recalling firm for further instructions.
The recalled product
- Product
- EENT PACK I CUSTOMED CONTENT: (2) TOWEL ABSORBENT 15" X 20" (1) MAYO STAND COVER REINFORCED (1) BAG SUTURE FLORAL (1) SHEET ENT SPLIT 110" X 77" SMS (1) TABLE COVER REINFORCED 50" X 90" (1) DRAPE HEAD W!TAPE 44" X 26" (1) GOWN SURG. REINFORCED XLGE TOWEL/WRAP
- 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 900-2498
- 4 lots 112020356 112051968 112072870 113078527
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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