The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2430-2014·Announced 2014-09-10

Customed Recalls Cesarean Packs Due to Potential Packaging Integrity Issues

Customed, Inc. is recalling 420 units of EO-sterilized Cesarean Packs because packaging integrity may be compromised, posing a risk of 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 differ 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 420 units of EO-sterilized Cesarean Packs, product code 900-2005, across 14 specific lots. The recall is due to a determination that packaging integrity may be compromised on these items. The affected lots are: 111123199, 112030704, 112041279, 112051918, 112083420, 112125056, 113036459, 113047202, 113057860, 113078296, 113088780, 113109780, 140211726, and 140412462.

The compromised packaging integrity could result in product contamination or a loss of sterility condition, which presents a potential risk of injury to patients. The affected 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 check their inventory for the specific lot numbers listed above. If the affected products are found, they should be removed from use and returned to Customed, Inc. for further instructions.

The recalled product

Product
CESAREAN PACK - (1) BABY BLANKET IMP. POLY ABS. (4) ABSORBENT TOWELS 15" x 20" LIF (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR LIF (2) LITE GLOVES LIF (1) BOWL PLASTIC WITH LID 80 oz. (1) C-SECTION DRAPE W/ POUCH 102" X 121 " X 78" (1) UTILITY BOWL 32 oz. (10) LAP…
Manufacturer
Customed, Inc
Category
Medical Device — Surgical Packs
Hazard

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 900-2005

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

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 →

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