Haemonetics Cell Saver 5 Fast Pack recallZ-0498-03 · Haemonetics Corporation · initiated Dec 17, 2002
Terminated All recalls posted in January 2003
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Haemonetics Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Disposable Set for Autologous Blood recovery may leak saline at the Y-connector
FDA root cause category: Other
What the company is doing
Haemonetics notified accounts of the recall on December 17, 2002 by fax. A hard copy of the same letter was sent to each customer via certified mail, return receipt on December 18 and 19. Users are requested to cease use of product and return product to Haemonetics.
Recall details
- Recall number
- Z-0498-03
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Dec 17, 2002
- Posted by the FDA
- Jan 30, 2003
- Recalling firm
- Haemonetics Corporation
- Quantity
- 15,150
- Product code
- CAC
- FDA submissions
- K932890
- Distribution
- Nationwide Canada
Product description
Haemonetics Cell Saver 5 Fast Pack List Number: 260
Code information (models, lots, serial numbers)
JJ02013 JJ02016 JJ02019 JJ02020 KK02002 KK02004 KK02005 KK02006 KK02007 KK02008 KK02013 KK02016 KK02017 KK02019 KK02021 KK02023 KK02025 LL02002 LL02005 LL02007 LL02008 LL02010 LL02011 LL02013 LL02014 LL02016 LL02017 LL02021 LL02023 LL02024 MM02001 MM02002 MM02003 MM02004 MM02005 MM02006
Other devices under the same FDA submission
2 devices cleared under K932890 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- HAEMONETICS CELL SAVER 5/5+ SYSTEMS 00261-00Haemonetics Corporation · Apparatus, Autotransfusion3 reports
- HAEMONETICS CELL SAVER 5/5+ SYSTEMS 00263-00Haemonetics Corporation · Apparatus, Autotransfusion3 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 25342).
- Z-0499-03 · TerminatedHaemonetics Cell Saver 5 Fast Pack with Filtered Reservoir List Number: 260F
- Z-0500-03 · TerminatedHaemonetics Basic Low Volume (125ml) Cell Saver 5 Bowl Set List Number: 261
- Z-0501-03 · TerminatedHaemonetics High Speed Cell Saver Bowl Set List Number: 263
- Z-0502-03 · TerminatedHaemonetics Cell Saver 5 Low Volume (125mL) Fast Pack List Number: 265
- Z-0503-03 · TerminatedHaemonetics Cell Saver 5 Low Volume (12ml) Fast Pack with Filtered Reservoir List Number: 265F
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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