Customed Extremity Pack Recall Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling Extremity Packs (code 900-2615) 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 classification is Class I, and the rubric states that if the agency's own classification is FDA Class I, the score must never go below 4.
Plain-English summary
Customed, Inc. is recalling Extremity Packs, catalog code 900-2615, due to a potential compromise in packaging integrity. The recalled product is an EO sterilized surgical convenient pack packaged in a polyester/polyethylene breather bag with Tyvek double vents. The pack contains various surgical items, including lap sponges, elastic bandages, surgical blades, drapes, gowns, and other medical supplies.
The recall is being issued because the possibility exists that the packaging integrity may be compromised on different catalog numbers across multiple lots. 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 product consists of 6 lots (272 packed units, with multiple units per lot) with the following lot numbers: 113099520, 131110253, 131210797, 140211867, 140312138, and 140412662. The 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 Customed, Inc. for further instructions.
The recalled product
- Product
- Extremity Pack, code 900-2615, contains: (5) LAP SPONGE PREWASH 18" X 18" XRD (1) ELASTIC BANDAGE WITH VELCRO 4 X 5 (2) BLADE SURGICAL# 15 STAINLES STEEL (4) DRAPE UTILITY WITH TAPE (1) GOWN XL SMS IMPERVIOUS REINFORCED ( 1) GOWN SURG REINFORCED LARGE TOWEL & WRAP (1)…
- 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)
- 900-2615
- 6 lots: 113099520 131110253 131210797 140211867 140312138 140412662
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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