FDA Device recall Z-2558-2014
CollectEVAC, Sterile device with tubing and adaptor for use with ACMI and STORZ/Wolf resectoscopes
- FDA Device
- Class II
- terminated
- Published 2014-09-03
On 2014-09-03 the FDA classified a Class II recall of CollectEVAC, Sterile device with tubing and adaptor for use with ACMI and STORZ/Wolf resectoscopes by Civco Medical Instruments, citing A pinhole leak identified in the packaging of the recalled product potentially could compromise the sterility of the product.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2558-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-08-01 |
| Published | 2014-09-03 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Civco Medical Instruments |
| Distribution | AZ, IL, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, SD, TN, VA, WI |
Product
CollectEVAC, Sterile device with tubing and adaptor for use with ACMI and STORZ/Wolf resectoscopes. Part number 610-954. Rx only. Sterile EO. The product is intended to be used to perform irrigation, tissue collection, and/or straining functions during transurethral prostate or bladder surgery.
Reason
A pinhole leak identified in the packaging of the recalled product potentially could compromise the sterility of the product.
Identifiers
| code_info | Lot numbers: M431760, M431710, M426580, M430200, M423010 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2558-2014%22
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