Groshong 3 Fr. Single-Lumen PICC Intermediate Tray with Safety Introducer, Reorder Number 7717300, Bard Access Systems,
FDA device recall Z-0865-2011 · posted 2011-01-06 · Terminated
Recall details
- Recalling firm
- Bard Access Systems
- Reason for recall
- Prepackaged sterile latex gloves beyond their expiration date were packaged in surgical kits.
- Action taken
- BARD Access Systems sent an URGENT: GROSHON* 3 FR SINGLE-LUMEN PICC INTERMEDIATE TRAY WITH SAFETY INTRODUCER RECALL letter dated December 10, 2010. The letter identified the product, the problem,and the action to be taken by the customer. Customers were instructed to examine their inventory and quarantine the product subject to recall, discontinue use, and cease further distribution of any the affected product. If the product was further distributed, those customers were to be notified immediately with a copy of the recall notification letter. Any remaining product was to be returned to Bard. For information regarding this recall call 800-290-1689.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- LJS
- Quantity affected
- 195 units
- Distribution
- Nationwide Distribution including AL, AZ, CA, GA, IA, MN, MO, NE, NJ, NY, OH, OR, SD, and WI.
- Date initiated
- 2010-12-10
- Date posted
- 2011-01-06
- Date terminated
- 2011-05-04
- Location
- Salt Lake City, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 3.0 FR GROSHONG PERIPHER INSERT CENT VENOUS CATH (K926331) | Bard Access Systems, Inc. | 1994-03-07 |