Customed Recalls Debridement Trays Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling specific lots of Debridement Trays (code 900-2702) 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. has initiated a recall of the Bandeja para Debridacion (Debridement Tray), code 900-2702. The recalled product is an EO sterilized surgical convenient pack packaged in a polyester/polyethylene breather bag with Tyvek double vents. The tray contains various surgical instruments and supplies, including Adson tissue forceps, gauze sponges, iris scissors, towels, drapes, Chlorascrub swabsticks, a Kutier tray, a scalpel with handle, and a wrapper.
The recall is being conducted because Customed determined that there is a possibility that packaging integrity may be compromised on different catalog numbers across multiple lots. This potential compromise could result in an injury to the patient due to product contamination or the loss of the product's sterility condition.
The recall affects 4 lots totaling 100 units, with multiple units per lot. The specific lot codes are 131110501, 140111072, 140211830, and 140312140. These 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. Healthcare facilities and consumers should stop using these products and contact the manufacturer for further instructions.
The recalled product
- Product
- Bandeja para Debridacion, code 900-2702, contains: (1) FORCEP ADSON TISS (20) GAUZE SPONGES 4 X 4 12PL Y (1) SCISSORS IRIS STRAIGHT 4.5 W/PROTECTOR TIP (1) TOWEL 3 PLY POLY 13 X 18 (1) DRAPE 18 X 26 WHITE/WHITE POLYPROPYLENE (1) CHLORASCRUB SWABSTICK 1.6 ML (1) TRAY…
- 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 (2)
- Code 900-2702
- 4 lots: 131110501 140111072 140211830 140312140
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.
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