Customed Recalls Chole Cystectomy All Endo System Due to Packaging Integrity Concerns
Customed, Inc. is recalling Chole Cystectomy All Endo System kits 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 source text explicitly states that the packaging defect 'could result in an injury to the patient due to product contamination or loss of sterility condition.' This aligns with the rubric criterion for 'significant injury/property-damage reports' or risk-of-harm products where injury is a direct potential consequence of a structural defect, warranting a Severe classification.
Plain-English summary
Customed, Inc. is recalling the Chole Cystectomy All Endo System, code 900-3025. The recall involves one lot (131110114) consisting of 20 units. The product is an EO sterilized surgical convenient pack packaged in a polyester/polyethylene breather bag with Tyvek double vents.
The recall was initiated because Customed determined there is a possibility that packaging integrity may be compromised on different catalog numbers across multiple lots. This defect could result in an injury to the patient due to product contamination or the loss of the product's sterility condition.
The affected units 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 recalled product and contact the manufacturer for further instructions.
The recalled product
- Product
- Chole Cystectomy All Endo System , code 900-3025, contains: (1) TABLE COVER 44X 90 UF (1) SYRINGE 20ccW/O NDL LUER LOCK LIF (2) MAYO STAND COVER REINFORCED UF (1) NEEDLE HYPODERMIC (6) ABSORBENT TOWEL 15 X 20 UF (1) NEEDLE HYPODERMIC 22G X 1Y. UF (4) UTILITY DRAPE WIT
- Manufacturer
- Customed, Inc
- Category
- Medical Device — Surgical Kits
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)
- Code 900-3025
- 1 lot: 131110114
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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