Customed Recalls Cesarean Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 1,784 units of EO sterilized Cesarean 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 (loss of sterility/contamination) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Customed, Inc. is recalling 1,784 units of EO sterilized Cesarean Packs across 16 lots. The recall was initiated because the company determined there is a possibility that packaging integrity may be compromised on different catalog numbers. The affected product is a surgical convenient pack packaged into a polyester/polyethylene breather bag with Tyvek double vents.
The compromised packaging integrity could result in an injury to the patient due to product contamination or loss of sterility condition. The recall covers 16 specific lots with product code 900-921, including lot numbers 110061474, 112114590, 113026118, 113036391, 113057414, 113057820, 113078478, 113078607, 113099298, 113099579, 131110080, 131110413, 131110590, 131210974, 140111455, and 140211743.
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 the affected lots and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- CESAREAN PACK- (1) COVER TABLE REINFORCED 50" X 90" (2) TOWELS ABSORBENT 15" X 20" (1) BABY BLANKET PRINTED (1) BOWL PLASTIC WITH LID 80oz. (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR (1) CORD UMBILICAL CLAMP (1) MUCUSTRAP 20cc, 10FR. (1) BOWL UTILITY 32oz (1) C-SECTION DR
- Manufacturer
- Customed, Inc
- Category
- Medical Device — Surgical Packs
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 900-921
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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