Customed Recalls Tummy Tuck and Liposuction Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling Tummy Tuck and Liposuction 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 pack) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Customed, Inc. is recalling Tummy Tuck and Liposuction Packs, code 900-2661, due to a potential compromise in packaging integrity. The recalled items are EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bags with Tyvek double vents. The recall involves one lot (140312417) consisting of 12 units.
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 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 purchased or received these specific surgical packs should stop using them immediately. Users should contact Customed, Inc. for further instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- Tummy Tuck and Liposuction Pack, code 900-2661, contains: ( 1) DRAPE % ECONOMY 53 X 77 (3) GOWN SOFT SMS STANDARD X-LARGE SET IN SLEEVE (3) TOWELS ABSORBENT 15 X 20 (1) MAYO STAND COVER REINFORCED (1) TABLE COVER REINFORCED 50 X 90 ( 1) SUTURE BAG FLORAL (6) TOWEL CLOTH HU
- 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 900-2661
- 1 lot: 140312417
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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