Pedi-Pak Pedi-Syringe Filter 30 mL Becton Dickinson Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and
FDA device recall Z-2667-2014 · posted 2014-09-18 · Terminated
Recall details
- Recalling firm
- Genesis BPS, LLC.
- Reason for recall
- Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes.
- Action taken
- Genesis BPS sent an Urgent Medical Device Recall letter with a Recall Letter/Confirmation Form on July 17, 2014 to all affected customers. Customers were asked to immediately examine their inventory and quarantine product subject to recall. In addition, if there is further distribution of the product, customers should be identified and be notified of the recall. Product use should be discontinued and disposed of according to applicable federal regulations and internal protocols. The attached confirmation form should be completed and returned to Genesis by either fax or (201) 708-1104 or e-mail (info@genesisbps.com). Questions can be directed to (201) 708-1400 ext 2004 (9:00 and to 5:00 pm EST). For questions regarding this recall call 201-488-1174.
- Root cause
- No Marketing Application
- Status
- Terminated
- Product code
- BRZ
- Quantity affected
- 7560 units
- Distribution
- Nationwide Distribution & Switzerland
- Date initiated
- 2014-07-17
- Date posted
- 2014-09-18
- Date terminated
- 2016-03-04
- Location
- Hackensack, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 30 ML OR 60 ML PEDI-SYRINGE FILTER (K050805) | Blood Products Specialties, LLC | 2005-06-20 |