Kimberly-Clark / Ballard TRACH-CARE* MAC (Multi Access Catheter) for Neonates
FDA device recall Z-1083-03 · posted 2003-08-06 · Terminated
Recall details
- Recalling firm
- Ballard Medical Products
- Reason for recall
- Incorrect plug was included in the multi access catheter pkg. When inserted in the 'Y' it may disengage, allowing a leak of ventilator gases.
- Action taken
- All consignees were notified by letter on 06/13/2003.
- Root cause
- Other
- Status
- Terminated
- Product code
- BSY
- Quantity affected
- 500 units
- Distribution
- Nationwide and to Belgium, Canada, Colombia, Germany, Japan, Norway, South Africa, Sweden, Switzerland, Turkey, United Kingdom.
- Date initiated
- 2003-06-13
- Date posted
- 2003-08-06
- Date terminated
- 2003-11-24
- Location
- Draper, UT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRACH CARE CATHETER (K872621) | Ballard Medical Products | 1987-09-15 |