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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sterile surgical supplies) where injury has not yet been reported, fitting the criteria for a High severity score.
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 REINFO
- Manufacturer
- Customed, Inc
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
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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