Customed Recalls Neuro Surgical Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling 37 lots of NEURO PACK 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 (injury due to contamination or loss of sterility) for a medical device, but the source text does not report any actual illnesses or injuries, fitting the criteria for a High severity score.
Plain-English summary
Customed, Inc. is recalling 37 lots of NEURO PACK surgical kits, totaling 858 units. These kits contain various surgical supplies, including table covers, gowns, towels, and drapes, which are ethylene oxide (EO) sterilized and packaged in polyester/polyethylene breather bags with Tyvek double vents.
The recall was initiated because the company determined there is a possibility that the packaging integrity may be compromised on different catalog numbers. This defect could result in an injury to the patient due to product contamination or a loss of the sterile condition of the medical devices.
The affected products were distributed worldwide, including nationwide in the United States (specifically mentioning Florida, Puerto Rico, and the US Virgin Islands) and in the countries of Tortola, Trinidad, Dominican Republic, Costa Rica, and Mexico. The specific product code is 900-752. Users should check their inventory against the 37 listed lot numbers provided in the official recall notice to determine if they are affected.
The recalled product
- Product
- NEURO PACK- (1)TABLE COVER 44" x 90" (1) GOWN SURGEON REINFORCED X-LARGE TIWRAP (1) GOWN IMPERVIOUS REINFORCED X-LARGE SMS (1) BAG SUTURE FLORAL (1) MAYO STAND COVER REINFORCED LIF (2) TOWELS ABSORBENT 15" X 20" LIF (4) DRAPE UTILITY WITH TAPE LIF (1) U-DRAPE 60" X 70" W
- Manufacturer
- Customed, Inc
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 (1)
- Product code 900-752
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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