Arrow 4FR Peripherally Inserted Central Catheter (PICCs) Kits. Product numbers: ASK-01451-BMH; ASK-05041-CHC; ASK-05041-
FDA device recall Z-1682-2010 · posted 2010-05-26 · Terminated
Recall details
- Recalling firm
- Arrow International Inc
- Reason for recall
- Tight fit in sheath. Arrow has received complaints of the PICC catheter fitting too tightly in the "kit supplied" peelable sheath. In some cases, clinicians have been unable to insert the catheter through the peelable sheath during the insertion procedure. If the catheter will not pass through the sheath, the clinician is required to place a guide wire back into the sheath, remove the sheath, a
- Action taken
- Arrow International issued an Urgent Medical Device Recall letter dated 3/29/10 to inform their customers of the problem and the need to return the product.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LJS
- Quantity affected
- 6719
- Distribution
- Worldwide distribution: USA, Australia, Brazil, Canada, New Zealand, Hong Kong, Malaysia, and Chile.
- Date initiated
- 2010-03-29
- Date posted
- 2010-05-26
- Date terminated
- 2012-09-27
- Location
- Reading, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PRESSURE INJECTABLE PICC (K073451) | Arrow International, Inc. | 2008-01-15 |
| ARROW PRESSURE INJECTABLE PICC (K061289) | Arrow International, Inc. | 2006-08-24 |