Customed Recalls C-Section Surgical Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling C-Section surgical 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 text explicitly identifies the agency classification as Class I, which mandates a severity score of 5 (Critical) according to the rubric.
Plain-English summary
Customed, Inc. is recalling C-Section surgical packs due to a potential compromise in packaging integrity. The recalled items are EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bags with Tyvek double vents. The recall involves 4 lots totaling 600 units, with product code 900-921A and specific lot numbers 140312028, 140412706, 140513148, and 140513469.
The FDA has classified this as a Class I recall. The company determined that the possibility of compromised packaging integrity could result in an injury to the patient due to product contamination or the loss of the sterility condition. 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 stop using these specific surgical packs immediately. Users should check their inventory for the listed product code and lot numbers. If the products are found, they should be quarantined and returned to Customed, Inc. or the distributor in accordance with the recall instructions.
The recalled product
- Product
- C-SECTION SURGICAL PACK- (1) COVER TABLE REINFORCED 50" X 90" (2) TOWELS ABSORBENT 15" X 20" (1) MAYO STAND COVER REINFORCED (1) BABY BLANKET PRINTED (1 0) LAP SPONGES PREWASH 18" X 18" XRD (1) BOWL PLASTIC WITH LID 80oz. (1) BAG GLASSINE (2) NEEDLE & BLADE COUNTER 1 OC
- 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 (2)
- Product code 900-921A
- 4 lots: 140312028 140412706 140513148 140513469
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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