Customed Recalls Tummy Tuck Packs Due to Potential Packaging Compromise
Customed, Inc. is recalling Tummy Tuck 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 Tummy Tuck Packs, code 900-2684, due to a potential compromise in packaging integrity. The recall involves 2 lots (112093646 and 113057473) totaling 75 units. The product is an EO sterilized surgical convenient pack packaged into a polyester/polyethylene breather bag with Tyvek double vents.
The recall was initiated because the compromised packaging could result in product contamination or loss of sterility condition, which poses a risk of injury to the patient. 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 who have these specific lots of Tummy Tuck Packs should stop using them immediately. Users should contact Customed, Inc. for further instructions on how to return or dispose of the affected products.
The recalled product
- Product
- Tummy Tuck Pack, code 900-2684, contains: (3) GOWN SOFT SMS STD XLGE SET IN SLEEVE ( 1) CAUTERY PENCIL PUSH BOTTOM ( 1) TUBE SUCTION CONNECT ( 1) MAYO STAND COVER REINFORCED ( 1) SKIN MARKER INK W LABEL (2) TABLE COVER REINFORCED 50 X 90 ( 1) RULER 6 (6) TOWEL CLOTH HUCK
- 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 900-2684
- 2 lots: 112093646 113057473
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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