Terumo Clirans Series EE Excebrane Hollow Fiber Dialyzers; a wet model single use dialyzer consisting of hollow fiber me
FDA device recall Z-0792-05 · posted 2005-05-03 · Terminated
Recall details
- Recalling firm
- Asahi Medical Co Ltd
- Reason for recall
- Exposure to freezing temperatures may damage the hollow fiber dialyzers and result in blood leaks during dialysis.
- Action taken
- Asahi sent Henry Schein, Inc. a recall letter dated 3/30/05, requesting the recall of the affected lots of Asahi labeled product, and Henry Schein, Inc. recalled the Asahi labeled dialyzers by letter dated 3/31/05, with a copy of the Asahi 3/30/05 letter. The accounts were informed that the dialyzers may have been exposed to temperature variances during distribution, and werw requested to cease distribution/use of the specific lots listed and return them to Henry Schein for credit. The recall was expanded to include the Terumo labeled dialyzers distributed by Asahi by Henry Schein letter dated 4/13/05, accompanied by a Terumo letter dated 4/8/05, sent to the accounts via first class mail on 4/14/05. The instructions were the same as in the 3/31/05 letter. A revised letter dated 4/21/05 was sent on 4/25/05, correcting the Henry Schein product codes involved in the Terumo labeled product. Any questions were directed Asahi Kasei Medical Co. at 847-498-8500.
- Root cause
- Other
- Status
- Terminated
- Product code
- KDI
- Quantity affected
- 5,479 units
- Distribution
- Nationwide and Puerto Rico
- Date initiated
- 2005-03-31
- Date posted
- 2005-05-03
- Date terminated
- 2006-07-10
- Location
- Chiyoda Ku, Japan
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CLIRANS E-SERIES HOLLOW FIBER DIALYZERS (K003425) | Terumo Medical Corp. | 2001-02-01 |