Customed Recalls C-Section Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 30 lots of C-Section 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 30 lots of C-Section Packs, which contain various surgical items including table covers, towels, gowns, and surgical blades. The recall involves 1,392 units distributed worldwide, including the United States (nationwide, specifically Florida, Puerto Rico, and USVI) and several international countries such as Tortola, Trinidad, Dominican Republic, Costa Rica, and Mexico.
The recall was initiated because Customed determined there is a possibility that the packaging integrity of these products may be compromised. This defect could result in product contamination or a loss of sterility, which poses a risk of injury to patients. The affected products are EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bags with Tyvek double vents.
Healthcare facilities and consumers who have these specific lots of C-Section Packs should stop using them immediately. The affected product code is 900-998, and the specific lot numbers are listed in the official recall documentation. Users should contact Customed, Inc. for further instructions on how to return or dispose of the recalled items.
The recalled product
- Product
- C-SECTION PACK - (1) TABLE COVER REINFORCED 50" X 90" L/F (3) TOWELS ABSORBENT 15" X 20" L/F (1) BABY BLANKET (1 0) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (1) GOWN SURG. SMS POLY-REINF BREATHABLE IMPERV XL T/ WRAP LEVEL IV (2) PAD OBSTETRICAL XL LIF (1) LITE GLOVE LIF (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 (1)
- Product code 900-998
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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