Customed Recalls Face Lift Surgical Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling Face Lift surgical packs (Code 900-3083) 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 (injury due to contamination or loss of sterility) where injury has not yet been reported, fitting the High severity criteria for risk-of-harm products.
Plain-English summary
Customed, Inc. is recalling 32 units of Face Lift surgical packs, Code 900-3083, across five specific lots. The recall is due to a determination that packaging integrity may be compromised on these items. The affected lots are identified by the following codes: 113109930, 131210851, 131210953, 140111437, and 140312196.
The compromised packaging integrity could result in product contamination or a loss of sterility condition, which poses a risk of injury to patients. The affected products are EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bags with Tyvek double vents.
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 specific lots and contact the recalling firm for further instructions.
The recalled product
- Product
- Face Lift , Code 900-3083, contains: (I) SHEET ENT SPLIT 110" X 77" LIF (I) COVER TABLE REINFORCED 50" X 90" LIF (I) DRAPE HEAD WITH TAPE 44" X 26" LIF (I) COVER MAYO STAND REINFORCED LIF (I) BAG SUTURE FLORAL LIF (3) GOWN STANDARD LARGE SMS VEL/NE LABEL SAMPLE (I) COUNTE
- 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)
- 900-3083
- 5 lots: 113109930 131210851 131210953 140111437 140312196
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.
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