Customed Recalls Labor and Delivery Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling 3,448 units of Labor and Delivery Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source metadata explicitly identifies the agency classification as 'Class I'. According to the severity rubric, an FDA Class I recall mandates a score of 5 (Critical) regardless of other factors, as it indicates a reasonable probability of serious adverse health consequences or death.
Plain-English summary
Customed, Inc. has initiated a recall of its Labor and Delivery Packs, which include various surgical and obstetrical supplies such as table covers, absorbent towels, and surgical gowns. The recall affects 34 lots totaling 2,648 units. The company determined that there is a possibility that the packaging integrity of these items may be compromised.
The compromised packaging could result in product contamination or a loss of sterility, which poses a risk of injury to patients. The affected products were distributed worldwide, including in the United States (nationwide, 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 who have these products should stop using them and contact Customed, Inc. for instructions on how to return the items. The recall is classified as Class I by the FDA, indicating a reasonable probability that the use of the product will cause serious adverse health consequences or death.
The recalled product
- Product
- Customed LABOR & DELIVERY PACK - Includes: (1) TABLE COVER 44" x 90" (2) LEGGINS WITH/7" CUFF 30" x 42" (5) ABSORBENT TOWELS 15" x 20" LIF (1) BABY BLANKET PRINTED LIF (2) PAD OBSTETRICAL XLGE LIF (1) EAR ULCER SYRINGE 2oz. LIF (1) BABY BLANKET POLY ABS. IMP. LIF (1) Pr
- 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 900-168
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.
See all 233 products in this recall →Related recalls
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