Customed Recalls Laparotomy Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 2,233 units of EO sterilized surgical laparotomy packs because packaging integrity may be compromised, risking product contamination or loss of sterility.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as a Class I recall, and the rubric specifies that FDA Class I recalls must be scored as 4 (Severe) or higher.
Plain-English summary
Customed, Inc. is recalling 2,233 units of EO sterilized surgical laparotomy packs (Product code 900-2492) across 12 lots. The recall is due to a determination that packaging integrity may be compromised on different catalog numbers. The affected products are packaged into polyester/polyethylene breather bags with Tyvek double vents.
The compromised packaging integrity could result in an injury to the patient due to product contamination or loss of sterility condition. The agency has classified this recall as Class I.
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 products and contact Customed, Inc. for instructions on return or replacement.
The recalled product
- Product
- LAPAROTOMY PACK Ill (4) CUSTOMED CONTENT: (4) TOWEL ABSORBENT 15" X 20" (2) GOWN XLARGE SMS IMPERVIOUS REINFORCED (1) COVER MAYO STAND REINFORCED (2) DRAPE SHEET 41" X 58" SMS (4) DRAPE UTILITY WITH TAPE (1) BAG SUTURE FLORAL (1) DRAPE T LAPAROTOMY 102" X 78" X 1
- 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 900-2492
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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