U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Agent, absorbable hemostatic, collagen based - Product Code LMF
원인
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.
조치
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 the count on the Business Reply Form.
6. Complete and Fax the enclosed Business Reply Form to 888-871-7109.
7. Return all units of the recalled product and accompanying packing slip using the prepaid UPS Return shipping label to:
Stericycle, Inc.
2670 Executive Dr.
Suite A
Indianapolis,IN 46241
The US recall notification letters were sent via commercial carrier (UPS Next Day Service & US Postal Service Next Day Air Saver). International recall notification will utilize local contacts in each region and countries. The notifications were handled by Baxter regional representative and coordinated to be initiated in the same time.
If you have questions, contact Stericycle, Inc. at 1-800-668-4391.
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.
제품 설명
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.