Customed Recalls EO Sterilized Surgical Shoulder Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling 327 units of EO sterilized surgical shoulder 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 16 lots of EO sterilized surgical shoulder packs, totaling 327 units. The affected products include various surgical items such as table covers, drapes, gowns, towels, syringes, needles, and surgical blades packaged in polyester/polyethylene breather bags with Tyvek double vents. The recall is limited to specific product code 900-1985 and 16 distinct lot numbers.
The recall was initiated because Customed determined that there is a possibility that 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 source text does not specify the exact number of affected units per lot or the specific dates of distribution.
The recalled product
- Product
- SHOULDER PACK- CUSTOMED- (1) TABLE COVER REINFORCED 50" x 90" LIF (2) MAYO STAND COVER REINFORCED L/F (1) U-DRAPE 60" X 70" WITH TAPE SPLIT (4) TOWELS ABSORBENT 15" X 20" LIF (4) DRAPE UTILITY WITH TAPE LIF (2) GOWN IMPERVIOUS EXTRA REINFORCED LARGE (1) SHEET DRAPE 70"…
- 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 (1)
- Product code 900-1985
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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