Customed Recalls EO Sterilized Surgical Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling EO sterilized surgical packs 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 specific lots of EO sterilized surgical convenient packs, identified by code 900-2582. The recalled items include various surgical supplies such as gowns, table covers, drapesheets, towels, and surgical blades 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 the loss of the product's sterility condition.
The affected products were distributed worldwide, including nationwide in the United States (specifically noting Florida, Puerto Rico, and the US Virgin Islands) and in the countries of Tortola, Trinidad, Dominican Republic, Costa Rica, and Mexico. The recall involves 2 lots with a total of 140 units. Consumers and healthcare facilities should stop using these products and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Plastic Pack Customed, code 900-2582 (1) GOWN LGE SMS IMP REINF L/F (1) GOWN SURG. REINF LGE TMJRAP LIF (1) MAYO STAND COVER REINF LIF (1) TABLE COVER REINF 50" X 90" LIF (4) (1) PVP PAINT 8" STICK SPONGE (2) DRAPESHEET 41X A¿MED LIF (3) TOWELS ABSORBENT 15 X 20 LIF…
- 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)
- 900-2582
- 2 lots: 112030835 112041310
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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