Boston Scientific/MEDI-TECH brand Fascial Dilator, 8 FR(2.7 mm), sterile, single use only, model M001481541; Catalog No.
FDA device recall Z-1104-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corp
- Reason for recall
- Labeling mix-up as to product size; 8FR may be labeled 10FR and vice versa.
- Action taken
- Recall letters dated June 16, 2004 were sent to consignees requesting product return.
- Root cause
- Other
- Status
- Terminated
- Product code
- DRE
- Quantity affected
- 1840
- Distribution
- Nationwide and Netherlands.
- Date initiated
- 2004-06-16
- Date posted
- 2004-07-20
- Date terminated
- 2005-02-11
- Location
- Spencer, IN
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