The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2433-2014·Announced 2014-09-10

Customed Recalls Open Heart Surgical Tray Packs Due to Packaging Integrity Concerns

Customed, Inc. is recalling Open Heart Tray 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 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 specific lots of Open Heart Tray Packs (Product Code 900-2114) due to a potential compromise in packaging integrity. The recall involves 12 lots totaling 88 units, which were distributed nationwide in the United States, including Puerto Rico and the US Virgin Islands, as well as to several international countries.

The company determined that the packaging integrity of these surgical packs may be compromised. This defect could result in product contamination or a loss of sterility, which poses a risk of injury to patients if the products are used in surgical procedures.

Healthcare facilities and consumers who have these specific products should stop using them immediately. The affected lots are identified by the following lot numbers: 112030719, 112041222, 112051939, 112083124, 112093924, 112125069, 113025796, 113026055, 113026076, 113036761, 113057459, and 113088787.

The recalled product

Product
OPEN HEART TRAY PACK A CONTENTS: (1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE LIF (1) MAYO STAND COVER REINFORCED L/F (3) TOWEL ABSORBENT 15" X 20" LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) SPLIT SHEET BILATERAL 84" X 80" (12) % SHEET 60" X 77" DRAPE…
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 (1)

  • Product code 900-2114

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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