Central Venous Catheterization Kit with Blue FlexTip Catheter; Product code: AK-04301; Exp. Dates Feb 2018 - Nov 2018
FDA device recall Z-0657-2018 · posted 2018-02-20 · Terminated
Recall details
- Recalling firm
- Arrow International Inc
- Reason for recall
- These finished good kits may contain the incorrect Springwire Guide (SWG).
- Action taken
- On October 17, 2017 an Urgent Medical Device recall letter from Arrow International was issued to customers requesting that customers review their inventory for product, which should immediately be discontinued and quarantined. The products are then to be returned to the firm. Questions or concerns can be directed to: Customer Service at 18662466990.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DQY
- Quantity affected
- 5,926 total
- Distribution
- Distribution US Nationwide
- Date initiated
- 2017-10-17
- Date posted
- 2018-02-20
- Date terminated
- 2020-04-14
- 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 |