| Date Initiated by Firm | July 17, 2014 |
|---|
| Date Posted | September 18, 2014 |
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| Recall Status1 |
Terminated 3 on March 04, 2016 |
| Recall Number | Z-2667-2014 |
|---|
| Recall Event ID |
68874 |
| 510(K)Number | K050805 |
|---|
| Product Classification |
Set, blood transfusion - Product Code BRZ
|
| Product | Pedi-Pak Pedi-Syringe Filter 30 mL Becton Dickinson Syringe
Rx Only Genesis BPS, LLC
The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion |
|---|
| Code Information |
Cat #405-530BD Lot #3640-23476; 3640-23506; 3640-24153; 3640-24206; 3640-24398; 3640-24485; 3640-24517; 3640-23969; 3640-24330; 3640-24521 |
| FEI Number |
1000527169
|
Recalling Firm/
Manufacturer |
Genesis BPS, LLC.
65 Commerce Way
Hackensack NJ 07601-6302
|
| For Additional Information Contact | Ms. Michelle Kurus
201-488-1174 |
|---|
Manufacturer Reason
for Recall | Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes. |
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FDA Determined
Cause 2 | No Marketing Application |
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| Action | 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. |
|---|
| Quantity in Commerce | 7560 units |
|---|
| Distribution | Nationwide Distribution & Switzerland |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database | 510(K)s with Product Code = BRZ
|
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