FDA Medical Device Recalls (openFDA)
Civco Medical Instruments Inc: CIVCO Latex Free NeoGuard Transducer Cover, Ref 676-117, Sterile (2.6 x 30cm) cover, packaged 24/box. The firm name on the label is CIVCO, Kalona, IA.
- Recall number
- Z-1607-2011
- Recalling firm
- Civco Medical Instruments Inc
- Product
- CIVCO Latex Free NeoGuard Transducer Cover, Ref 676-117, Sterile (2.6 x 30cm) cover, packaged 24/box. The firm name on the label is CIVCO, Kalona, IA.
- Status
- Terminated
- Initiated
- 2011-01-21
- Posted
- 2011-03-08
- Terminated
- 2013-07-09
- Reason
- Non-sterile transducer covers were incorrectly labeled as sterile and contained incorrect temperature storage information.
- Root cause
- Labeling design
- Action
- The recalling firm notified their customers via phone and e-mail letter entitled Urgent - Medical Device Correction, dated 1/21/11, explaining the reason for recall. The letter stated that the firm will replace the affected product and requested that customers dispose of the product from the affected lots. A response form was enclosed to report final disposition of the product and should be returned to the firm. If there are any questions, customers can call their customer service representative at 800-445-6741 between 8 am and 5 pm CST.
- Quantity
- 31/24-cover boxes
- Distribution
- Nationwide Distribution -- WA, CA, and MO.
- Lot, serial or model codes
- Lots M615880, M598520, M591150, and M581180.
- 510(k) numbers
- ["K013721"]
- PMA numbers
- not on file
- Product code
- ITX
- Firm FEI
- 1937223
- Firm city
- Kalona
- Firm state
- IA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28