The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2389-2014·Announced 2014-09-10

Customed Recalls Open Heart Surgical Trays Due to Packaging Integrity Concerns

Customed, Inc. is recalling Open Heart Surgical Trays 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 specific lots of Open Heart Surgical Trays (Pack A and Pack B) due to a potential compromise in packaging integrity. The recall involves 6 lots totaling 127 units. The affected products are EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bags with Tyvek double vents.

The recall was initiated because the compromised packaging could result in product contamination or a loss of sterility condition. This poses a risk of injury to patients if the non-sterile or contaminated products are used during surgical procedures.

The affected lots were distributed worldwide, including nationwide in the United States (specifically Florida, Puerto Rico, and USVI) and in the countries of Tortola, Trinidad, Dominican Republic, Costa Rica, and Mexico. Healthcare facilities and consumers who have these specific lot numbers should stop using the products and contact Customed, Inc. for instructions on return or replacement.

The recalled product

Product
OPEN HEART TRAY - - PACK A ( 1) CV SPLIT DRAPE W/ CLEAR AN EST SCREEN STD SMS LIF (5) DRAPE % ECONOMY 53" X 77" LIF ( 1) MAYO STAND COVER REINFORCED LIF (7) DRAPE UTILITY WITH TAPE L/F (8) HUCK CLOTH TOWELS WHITE L/F (20) HUCK CLOTH TOWELS BLUE LIF (1) MAYO TRAY LARGE…
Manufacturer
Customed, Inc
Category
Medical Device — Surgical Supplies
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 (2)

  • Product code 900-1393
  • 6 lots: 112041420 113078354 113109651 140211586 140312499 140613718

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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