Customed Recalls Surgical Packs Due to Potential Packaging Integrity Issues
Customed is recalling 567 units of 08 PAD PACK II surgical packs because packaging integrity may be compromised, risking 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 567 units of the 08 PAD PACK II surgical convenient packs. The recall involves three specific lots with product code 900-2464 and lot numbers 112020343, 112051958, and 112083317. These packs contain various surgical items, including towels, gowns, drapes, and umbilical cord clamps, and are EO sterilized.
The recall was initiated because Customed determined there is a possibility that the packaging integrity may be compromised on these units. If the packaging is compromised, it could result in product contamination or a loss of the sterile 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 should check their inventory for the specific lot numbers listed and contact Customed for instructions on how to return or dispose of the affected products.
The recalled product
- Product
- 08 PAD PACK II (2,3) CUSTOMED CONTENTS: (3) TOWEL ABSORBENT 15" X 20" (1) BOWL W/LID PLASTIC 80oz (1) GOWN XL SMS IMPERVIOUS REINFORCED (1) SHEET PLASTIC 44" X 65" (1) DRAPE UNDERBUTTOCK W/POUCH (1) UMBILICAL CORD CLAMP (1) BABY BLANKET 30" X 30" POLY ABSOR.IMP. (1) PAC
- 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)
- Product code 900-2464
- 3 lots 112020343 112051958 112083317
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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