Medcomp Duo-Flow 400XL Catheter, Hemo-Flow Catheter, SLX Catheter, Triple Lumen Infusion Catheter, CT rated PICC, Split
FDA device recall Z-1351-2015 · posted 2015-03-30 · Terminated
Recall details
- Recalling firm
- Medical Components, Inc dba MedComp
- Reason for recall
- Medcomp has initiated the recall of Duo-Flow 400XL Catheter, Hemo-Flow Catheter, SLX Catheter, Triple Lumen Infusion Catheter, CT rated PICC, Split Cath III, PC Split Cath III because the product shipped was out of specification. One BI (biological indicator) out of 21 on the sterilization load was out of specification.
- Action taken
- On or about 02/03/2015, Medcomp sales representatives notified the affected medical facilities and providing Medcomp's recall letter. This was accomplished by e-mail, telephone, or visit. Distributors for the international accounts were notified by Medcomp via e-mail. A copy of Medcomp's recall letter was attached. For AngioDynamics product- Medcomp notified AngioDynamics by e-mail of the product recall. Every consignee was requested to complete and return Page 2 of the recall letter verifying receipt of the recall and disposition of the product they received. AngioDynamics was requested to provide an account of the disposition for the total number of product they received.
- Root cause
- Process control
- Status
- Terminated
- Product code
- MSD
- Quantity affected
- 3152
- Distribution
- Worldwide Distribution.
- Date initiated
- 2015-02-05
- Date posted
- 2015-03-30
- Date terminated
- 2015-08-06
- Location
- Harleysville, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SPLIT CATH III (K111651) | Medical Components, Inc. | 2011-12-08 |
| 14.5F X 55CM HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-55, HFT-55 (K030502) | Medcomp | 2003-05-20 |
| HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-24, HFS-28, HFS-32, HFS-36, HFS-40 (K994105) | Medical Components, Inc. | 2001-10-03 |