Sterile Access & Return Line Set, 36" Length, Part # UM-872-36. Intended for use with medically prescribed hemodialysis
FDA device recall Z-0969-2013 · posted 2013-03-18 · Terminated
Recall details
- Recalling firm
- Molded Products Inc
- Reason for recall
- The recalled product leaks at the connection site.
- Action taken
- The firm's one customer was notified of the recall by phone call on 5/8/2012. The customer returned the affected product once the replacement product was received.
- Root cause
- Process control
- Status
- Terminated
- Product code
- KOC
- Quantity affected
- 1200 sets
- Distribution
- Distributed to one customer in Michigan.
- Date initiated
- 2012-06-19
- Date posted
- 2013-03-18
- Date terminated
- 2013-08-14
- Location
- Harlan, IA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO MALE TO MALE LUER ADAPTER (K003712) | Molded Products, Inc. | 2001-05-16 |