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.
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 (sterile surgical instruments) where injury has not yet been reported, fitting the 'High' severity criteria for potential 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 KUTIE
- 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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