Customed Recalls Face Pack FJG Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling Face Pack FJG surgical kits 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 kits) where injury has not yet been reported, fitting the 'High' severity criteria for potential contamination or loss of sterility.
Plain-English summary
Customed, Inc. is recalling one lot of Face Pack FJG surgical kits, code 900-3116. The recall involves 16 units distributed worldwide, including the United States (nationwide, specifically Florida, Puerto Rico, and USVI) and several international locations such as Tortola, Trinidad, Dominican Republic, Costa Rica, and Mexico. The specific lot number is 131210805.
The recall was initiated because Customed determined there is a possibility that the packaging integrity of the kits may be compromised. This defect could result in product contamination or a loss of the sterile condition, which poses a risk of injury to patients using the equipment. The affected kits contain various surgical supplies, including gowns, towels, needles, blades, and gloves, and are EO sterilized.
Healthcare facilities and consumers who have purchased or received these specific Face Pack FJG kits 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
- Face Pack FJG, code 900-3116, contains: (2) GOWN LARGE STANDARD SMS AAMIIII (2) TOWEL ABSORBENT 15" X 20" (1) COUNTER NEEDLE & BLADE 20C FOAM/MAG (1) COVER MAYO STAND REINFORCED (1) SHEET ENT SPLIT 11 0" X 77" SMS (1) COVER TABLE REINFORCED 44" X 78" (20) GAUZE SPONGE 4" X
- Manufacturer
- Customed, Inc
- Category
- Medical Device — Surgical Kits
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)
- 900-3116
- 1 lot: 131210805
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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