Customed Recalls Tummy Tuck Surgical Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling Tummy Tuck Pack-BOD 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 (sterile surgical packs) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Customed, Inc. has initiated a recall of Tummy Tuck Pack-BOD surgical packs, code 900-3026. The recall involves 24 units across two lots (lot numbers 113099551 and 140312148). These packs contain various surgical items, including gowns, towels, cautery pencils, and drapes, and are EO sterilized and packaged in polyester/polyethylene breather bags with Tyvek double vents.
The recall was issued because Customed determined there is a possibility that the packaging integrity may be compromised. This defect could result in product contamination or a loss of sterility condition, which poses a risk of injury to patients.
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. Users of these products should stop using them and contact the manufacturer for further instructions.
The recalled product
- Product
- Tummy Tuck Pack-BOD , code 900-3026, contains: (2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED AAMIIII (2) TOWELS ABSORBENT 15 X 20 (1) PENCIL CAUTERY PUSH BOTTOM (1) COUNTER NEEDLE/BLADE 20C FOAM/MAG (1) BOWL UTILITY QUART 32oz TURQ (1) COVER MAYO STAND REINFORCED (2) SKIN MAR
- 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)
- Code 900-3026:
- 2 lots: 113099551 140312148
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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