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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility…"
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"…
- 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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