Haemonetics High Speed Cell Saver Bowl Set recallZ-0501-03 · 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-0501-03
- 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
- 11302
- Product code
- CAC
- FDA submissions
- K932890
- Distribution
- Nationwide Canada
Product description
Haemonetics High Speed Cell Saver Bowl Set List Number: 263
Code information (models, lots, serial numbers)
J02115 J02131 J02142 J02150 J02162 G02081 G02086 G02092 G02103 G02133 G02141 H02007 H02015 H02024 H02038 H02102 H02108 H02120 H02147 H02157 H02165 H02239 H02249 J02032 J02040 J02049 J02058 J02061 J02076 J02172 J02194 J02208 K02015 K02027 K02037 K02045 K02056 K02066 K02139 K02161 K02171 K02208 K02217 K02224 K02236 L02002 L02049 L02059 L02093 L02103 L02113 L02144 L02163 L02199 M02002 M02010 M02014 M02022 M02027 M02035
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-0498-03 · TerminatedHaemonetics Cell Saver 5 Fast Pack List Number: 260
- 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-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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