Endosee convenience kits label non-sterile iodine pouches as sterile
Endosee System Convenience Kits with IV Tube are being recalled because they contain non-sterile iodine pouches while the peel away lid labels incorrectly identify them as sterile. 475 units affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
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: Risk-of-harm product: a non-sterile component labelled as sterile could be introduced into a sterile field, with no infection reported in the source.
Plain-English summary
The Endosee System Convenience Kit with IV Tube, model number ES-TRAY-IV, UDI-DI 60888937026674, is being recalled. The action covers 475 units across the lot numbers listed in the recall notice, including 344355, 550009229 and 550009230.
The stated reason is that the HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the peel away lid labels incorrectly identify the iodine pouches as sterile. The FDA classified the action as Class II. The source does not report any infection having occurred.
Distribution was nationwide in the United States, including Alabama, Arkansas, Arizona, California, Colorado, Connecticut and Delaware among other states. The kits are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the model number, UDI-DI and lot numbers above and follow the instructions issued by the manufacturer.
The recalled product
- Product
- Endosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV. Endosee System Convenience Kit with IV Tube.
- Manufacturer
- CooperSurgical, Inc.
- Category
- Medical Device — Procedure kit
- Affected units
- 475
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 (5)
- Model Number: ES-TRAY-IV. UDI-DI: 60888937026674. Lot Numbers: 344355
- 550009229
- 550009230
- 550009590
- 550013213.
Distribution
Part of a larger recall action
This product is one of 3 recalled by CooperSurgical, 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 3 products in this recall →Related recalls
Same manufacturer · CooperSurgical, Inc.
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