Customed Recalls Face Pack MRT Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling Face Pack MRT 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 (loss of sterility/contamination) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Customed, Inc. has initiated a recall of the Face Pack MRT (product code 900-2654). The recall involves 2 lots (112062214 and 112093599) totaling 112 units. The product is an EO sterilized surgical convenient pack packaged into a polyester/polyethylene breather bag with Tyvek double vents.
The recall was issued because Customed determined there is a possibility that packaging integrity may be compromised on different catalog numbers. This defect could result in an injury to the patient due to product contamination or loss of sterility condition.
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 stop using the affected lots and contact Customed, Inc. for instructions on return or replacement.
The recalled product
- Product
- Face Pack MRT, product code 900-2654, contains: (2) GOWN SOFT SMS STD X-LARGE SET IN SLEEVE LIF (2) TOWELS ABSORBENT 15 X 20 LIF (1) DRAPE INST. MAGNETIC 10 X 16 LIF (1) TRAY HALF DEEP (1) COVER MAYO STAND REINFORCED LIF (1) SHEET ENT SPLIT 110 X 77 SMS LIF (1) COVER TABLE
- 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)
- 900-2654
- 2 lots: 112062214 112093599
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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