Customed Recalls Cysto TUR Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 29 lots of Cysto TUR Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class I, which per the rubric mandates a minimum score of 4 (Severe) due to the potential for serious adverse health consequences from loss of sterility.
Plain-English summary
Customed, Inc. is recalling 29 lots of Cysto TUR Packs, which are EO sterilized surgical convenient packs containing various medical supplies such as utility bowls, specimen cups, gauze sponges, absorbent towels, drapes, gowns, and syringes. The recall involves 870 units distributed worldwide, including the United States (nationwide, Florida, Puerto Rico, USVI), Tortola, Trinidad, Dominican Republic, Costa Rica, and Mexico.
The recall was initiated because Customed determined that 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 affected product code is 900-430, and specific lot numbers are listed in the agency's recall record.
Healthcare facilities and consumers who have these specific lots of Cysto TUR Packs should stop using them immediately. They should contact Customed, Inc. for instructions on how to return or dispose of the affected products. The recall is classified as Class I by the FDA, 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
- CYSTO TUR PACK- - (1) UTILITY BOWL 32oz LIF (1) SPECIMEN CUP WITH CAP 4oz LIF (1 0) GAUZE SPONGE 4" X 4" 12PL Y LIF (4) ABSORBENT TOWELS 15" X 20" LIF (1) CYSTOSCOPY 'T' DRAPE 60" X 87" X 35" SMS STD LIF (2) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE LIF (2) LEGGINS WITH…
- 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 900-430
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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