Customed Recalls Laparoscopy Gyn Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling 648 units of Laparoscopy Gyn 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 classification is FDA Class I, which mandates a minimum score of 4 per the rubric, as it indicates a reasonable probability of serious adverse health consequences or death.
Plain-English summary
Customed, Inc. is recalling 24 lots of Laparoscopy Gyn Packs, totaling 648 units, due to a potential compromise in packaging integrity. The recalled products are EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bags with Tyvek double vents. The company determined that the possibility of compromised packaging could result in product contamination or a loss of sterility condition, which poses a risk of injury to patients.
The affected products were distributed worldwide, including nationwide in the United States (specifically noting Florida, Puerto Rico, and the US Virgin Islands) and in the countries of Tortola, Trinidad, Dominican Republic, Costa Rica, and Mexico. The specific product code is 900-618, and the recall involves 24 distinct lot numbers ranging from 109010109 to 140312178.
Healthcare facilities and consumers should stop using these products and contact Customed, Inc. for further instructions or a refund. The recall is classified as FDA Class I, indicating a reasonable probability that the use of or exposure to the violative product will cause serious adverse health consequences or death.
The recalled product
- Product
- LAPAROSCOPY GYN PACK - (1) TABLE COVER REINFORCED 44" X 78" (1) LAPAROSCOPY SHEET "T" SMS (3) TOWELS ABSORBENT 15" X 20" (1) SURGICAL BLADE#11 STAINLESS STEEL (1) MAYO STAND COVER REINFORCED (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK (2) LEGGINS WITH 7" CUFF 30" x 42" (1
- 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 900-618
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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