Customed Recalls Premium Cesarean Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling 730 units of Premium Cesarean Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
What this means for you
Illness, injury, or structural failure has been reported. 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. Per the rubric, if the agency's own classification is FDA Class I, the score must be at least 4 (Severe).
Plain-English summary
Customed, Inc. is recalling 730 units of Premium Cesarean Packs, product code 900-1294, across 18 lots. The recall involves EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bags with Tyvek double vents. The affected lots include 111030560, 111030815, 112020527, 112114630, 112124933, 113015688, 113026042, 113036408, 113057858, 113089182, 113109717, 131110166, 131210694, 140211638, 140312063, 140412594, 140513078, and 140513477.
The recall was initiated because Customed determined there is a possibility that packaging integrity may be compromised on different catalog numbers. This defect could result in an injury to the patient due to product contamination or loss of sterility condition. The agency has classified this recall as Class I.
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. Users should stop using the affected products and contact Customed, Inc. for further instructions.
The recalled product
- Product
- PREMIUM CESAREAN PACK- CUSTOMED- (1)BABY BLANKET IMP. 30" X 30" POLY ABSORBENT (3) TOWELS ABSORBENT 15" X 20" LIF (1) BOWL PLASTIC 80oz WITH LID (10) LAP SPONGE PREWASH XRD LIF (2) PAD OBSTETRICAL X-LARGE ST. (1) MAYO STAND COVER REINFORCED LIF (1) DRAPE SHEET 41 " X 58"
- 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 900-1294
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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