FDA Medical Device Recalls (openFDA)
Zimmer Inc.: Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number; 47-2550-002-10, 400 ml evacuators and 450 ml collection bags, 1/8 in. (10 FR.) O.D. middle perforated PVC drains with trocars, evaluator tubing and connectors, medium, contains 10, non-sterile, latex free, Zimmer, Dover, Ohio;
- Recall number
- Z-1456-2008
- Recalling firm
- Zimmer Inc.
- Product
- Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number; 47-2550-002-10, 400 ml evacuators and 450 ml collection bags, 1/8 in. (10 FR.) O.D. middle perforated PVC drains with trocars, evaluator tubing and connectors, medium, contains 10, non-sterile, latex free, Zimmer, Dover, Ohio;
- Status
- Terminated
- Initiated
- 2008-01-31
- Posted
- 2008-04-09
- Terminated
- 2009-11-12
- Reason
- Leakage; The kits may disassemble at the fluid collection port, which would present a risk of exposure to blood borne pathogens to health care providers should it occur during use.
- Root cause
- Process control
- Action
- Consignees were notified via Urgent Infection Control Recall letter dated 1/31/08 to examine their inventory and return the recalled lots. Custom kit packers were instructed in the same letter to recall these products/lots from their own customers.
- Quantity
- 34,354 (Recalls Z-1448/1458-2008)
- Distribution
- Worldwide-USA, Australia, Canada, Colombia, Denmark, Dubai, Italy, Japan, Mexico and Singapore.
- Lot, serial or model codes
- Lot Numbers: 32237200, 32285400, 32326900, 32349300, 32380000, 32413600, 32444100, 32471900, 32503500, 32538000, 32552400, 32580700, 32928800, 32980300, 33043400, 33121100, 33166500, 33222900, 33300500, 33328900, 33387100, 33432000, 60057314, 60075861, 60094646, 60113078, 60117514, 60134951, 60156026, 60176003, 60203020, 60227311, 60249134, 60278438, 60356862, 60389058, 60617386 and 60621549.
- 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