Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-110 (M001171100). EQL/33/7/2/100. Sterilized using Ethylene Oxide. Single Use Only. Legal Manufacturer Boston Scientific Cork Ltd., Business and Technology Park, Model Farm Rd, Cork, Ireland.
- Company
- Boston Scientific Corporation
- Recall Initiated
- September 29, 2009
- Posted
- November 13, 2009
- Terminated
- December 17, 2011
- Recall Number
- Z-0196-2010
- Quantity
- 9800 total (2373 US and 7427 OUS)
- Firm Location
- Maple Grove, MN
Reason for Recall
Boston Scientific is initiating a Recall Removal of numerous batches/lots of Equalizer Occlusion Balloon Catheter because the sterile barrier in the packaging of the affected product may be compromised. The outer pouch seal may be breached. If a compromised seal is not detected and a sterility-compromised catheter is used clinically, there is a risk of adverse health consequences.
Distribution
Worldwide. US distribution includes: AL, AR, AZ, CA, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT. NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and Washington D.C. and Puerto Rico. Worldwide distribution includes: Algeria, Argentina, Austria, Belgium, Brazil, Bulgaria, Canada, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Lithuania, Luxembourg, Malaysia, Morocco, Netherlands, Norway, Poland, Portugal, Qatar, Saudi Arabia, Serbia, Slovenia, South Korea, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Arab Emirates.
Lot / Code Info
Lot: 11612503, 11613167, 11649850, 11664333, 11675647, 11679806, 11687184, 11703304, 11703305, 11706256, 11706257, 11721527, 11747701, 11748426, 11748427, 11753300, 11818319, 11822020, 11822021, 11823536, 11823537, 11838168, 11872757, 11880388, 11892722, 11894939, 11895181, 11895182, 11905798, 11942328, 11960758, 11973985, 11975229, 11975230, 11981138, 11981139, 11984930, 11992156, 11996764, 12003798, 12003799, 12060855, 12060857, 12065124, 12133643, 12140443, 12143888, 12143890, 12147789, 12159640, 12167057, 12183330, 12185881, 12215326, 12215327, 12227669, 12235732, 12235733, 12235734, 12280629, 12299197, 12299198, 12299199, 12303046, 12303579, 12307240, 12319312, 12319313, 12319314, 12351534, 12351536, 12397165, 12397166, 12400869, 12400870, 12400871, 12419731, 12423640, 12424849, 12424850, 12424851, 12432156, 12438763, 12438764, 12438765, 12438766, 12438767, 12442597, 12535285, 12535286, 12582189, 12582625, 12590510, 12598481, 12598482, 12598483, 12598484, 12617284, 12617285, 12625391, 12625392, 12625393, 12636765, 12636766, 12640395, 12640396, 12640397, 12640398, 12640399, 12685132, 12709946, 12709947.
Root Cause
Other
Action Taken
An Urgent Medical Device Recall Removal letter dated 09/29/2009 was sent to affected facilities and addressed to Risk Manager / Field Action Contact, beginning 09/29/2009. The letter explained the issue and identified product. Customers were asked to identify affected product within their inventory, segregate it and immediately return it to Boston Scientific. Customers will receive replacements for all recalled product that is returned. Customers were also to fax back to Boston Scientific the Reply Verification Tracking Form. Questions regarding this Recall Removal are directed to the local Sales Representative.