FDA Medical Device Recalls (openFDA)
Zimmer Inc.: Surgivac Wound Drainage Device, 400 ml Surgivac 1/4" PVC w/trocar, 6,4mm, 19Fr, PVC, 107cm, large, sterile, latex free, Rx only; Zimmer, Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio; REF 00-5390-040-10.
- Recall number
- Z-1509-2008
- Recalling firm
- Zimmer Inc.
- Product
- Surgivac Wound Drainage Device, 400 ml Surgivac 1/4" PVC w/trocar, 6,4mm, 19Fr, PVC, 107cm, large, sterile, latex free, Rx only; Zimmer, Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio; REF 00-5390-040-10.
- Status
- Terminated
- Initiated
- 2008-01-29
- Posted
- 2008-09-19
- Terminated
- 2009-11-12
- Reason
- The sterility of the device may be compromised due to the possible presence of slits or pinholes in the packaging.
- Root cause
- Packaging process control
- Action
- Consignees were notified via recall letter dated 1/29/08 to locate and return the affected product. The recall action was expanded to additional products/lots via recall letter dated 3/17/08. Custom kit packers were instructed to notify their customers.
- Quantity
- not on file
- Distribution
- Nationwide, Australia, Canada, Chile, China, Czech Republic, Dubai, Ecuador, France, Germany, Greece, Hungary, Italy, Japan, Korea, Poland, Romania, Russia, Saudi Arabia, Serbia & Montenegro, Singapore, Slovakia, South Africa, Spain, and Switzerland.
- Lot, serial or model codes
- All lots manufactured on or before 1/18/08. Product has a 5 year expiration period.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GCY
- Firm FEI
- 1000220733
- Firm city
- Warsaw
- Firm state
- IN
- 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