Recall Z-1032-2015 ยท NZW Heparin, Vascular Access Flush
Fresenius Kabi USA, LLC
HEPFLUSH-10 (HEPARIN LOCK FLUSH SOLUTION, USP) 100 USP units per 10 mL (10 USP units per mL), Single Dose Vial, Rx only -- Fresenius Kabi USA, LLC -- NDC 63323-017-10, Product Code 1710
| Date | Jan 29, 2015 (initiated Dec 19, 2014) |
| Status | Terminated |
| Reason | The lot failed pH specification. |
| Root cause | Component design/selection |
| Action | Fresenius sent an URGENT DRUG RECALL Letter dated December 19, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. 1. Examine their stock immediately to determine if they have any product from the affected lot. If the consignee is a distributor, immediately notify your customers that have been shipped or may have been shipped this product/lot of this recall and direct them to discontinue distributing or dispensing the affected lot. Please have them prepare to return the product to Fresenius Kabi as instructed in th |
| Quantity | Domestic: 69,725 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092938 | HEPARIN LOCK FLUSH SOLUTION USP, MODELS 504401, 504411, 504505, 505701, 504901, 1710 App Pharmaceuticals, LLC, Jun 18, 2010 |