Arrow International, Inc. Two-Lumen CVC Kit with Blue Flex Tip Catheter. The multiple lumen catheter permits venous acce
FDA device recall Z-1965-2013 · posted 2013-08-14 · Terminated
Recall details
- Recalling firm
- Arrow International Inc
- Reason for recall
- Arrow is recalling the product due to a labeling inconsistency. One portion of the lidstock states the kit contains a 3-Lumen catheter while the rest of the lidstock correctly identifies the catheter as 2-Lumen.
- Action taken
- An "Urgent Medical Device Recall Notification" letter dated July 31, 2013 was sent to direct accounts requesting immediate discontinuation of use and quarantine of all affected product on hand. Negative responses were also requested and the immediate return of product to Arrow was authorized. Questions were directed to Customer Service at 800 343-2935.
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- DQY
- Quantity affected
- 156
- Distribution
- AL, PA, CT, NC, VA, KS, RI, AZ, NJ, and IL.
- Date initiated
- 2013-07-31
- Date posted
- 2013-08-14
- Date terminated
- 2015-04-28
- Location
- Reading, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| [CENTRAL VENOUS][MULTI-LUMEN] CATHETER W/FLEX TIP (K862056) | Arrow Intl., Inc. | 1986-08-25 |