Customed Cysto Tur Pack Recalled for Potential Packaging Integrity Issues
Customed is recalling Cysto Tur 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 (injury due to contamination or loss of sterility) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Customed, Inc. is recalling 37 lots of Cysto Tur Packs, which are EO sterilized surgical convenience packs containing multiple components such as leggings, drapes, towels, and table covers. The recall is due to a determination that packaging integrity may be compromised on different catalog numbers.
The compromised packaging could result in product contamination or a loss of sterility condition, which poses a risk of injury to patients. The affected units were distributed worldwide, including nationwide in the United States (specifically Florida, Puerto Rico, and USVI) and in the countries of Tortola, Trinidad, Dominican Republic, Costa Rica, and Mexico.
Healthcare facilities and consumers should stop using the affected products immediately. Users should check their inventory for the specific lot numbers listed in the recall notice and contact Customed, Inc. for further instructions on how to return or dispose of the recalled items.
The recalled product
- Product
- Customed Cysto Tur Pack, convenience pack include multiple components: legging with cuff, drape cystoscopy, towel absorbent & table cover. EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
- 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 900-080
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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