Recall Z-2340-2008 ยท LMF Agent, Absorbable Hemostatic, Collagen Based
Baxter Bioscience
FloSeal Endoscopic Applicator , Product Code 1500181. The product is indicated in surgical procedures (other than in neurosurgical, opthalmic, and urological) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
| Date | Sep 20, 2008 (initiated Jul 31, 2008) |
| Status | Terminated |
| Reason | The recall is being conducted as a precautionary measure due to potential discoloration of the FloSeal material noted in six (6) non-medical complaints during delivery by the Endoscopic Applicator. |
| Root cause | Pending |
| Action | An Urgent Product Recall Letter dated August 4, 2008, was issued with attached Product Recall Instructions and Customer Response forms to all consignees (addressed to ""Risk Manager" & "Surgery"). The recall letter informed the consignees of the reason for the recall and requested their customers: 1. Examine your inventory to determine the presence of product. 2. Immediately stop dispensing and distributing this product. 3. Quarantine the product affected by this recall immediately. 4. Contact any customers who may have received the recalled shipment. 5. Carry out a physical count and record t |
| Quantity | 10,751 units worldwide (2,742 units in US) |
| Distribution | Nationwide and worldwide to Puerto Rico, Colombia, Hong Kong, New Zealand, Australia, Austria, Belgium, Czech Republic, Denmark, Finland, France, Greece, Germany, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, Turkey, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.