Boston Scientific PT2 Moderate Support Guide Wire 185cm J-Tip, Catalog Number 38931-03 . Sold in single pack and 5-pack. PTCA Guide Wire with Hydrophilic Coating. Boston Scientific Guide Wires are steerable guide wires available in a variety of lengths and diameters. The distal tip is shapeable, or, alternatively, is available in a preshaped ''J'' tip. Made in USA.
This recall has been terminated (originally issued September 29, 2006).
- Company
- Boston Scientific
- Recall Initiated
- August 31, 2006
- Posted
- September 29, 2006
- Terminated
- June 26, 2007
- Recall Number
- Z-1540-06
- Quantity
- 3,654 total. 1,041-US, 2,613-Foreign
- Firm Location
- Maple Grove, MN
- Official Source
- View on FDA website ↗
Reason for Recall
The PT2 J-tip labeled guide wires may be missing the pre-formed J-tip. As a result, guide wires may have a straight tip instead of a pre-formed J-tip.
Distribution
Worldwide distribution --- including states of AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, NC, NE, NJ, NM, NV, OH, OK, PA, SC, TN, TX, WI, WV and Puerto Rico and countries of Austria, Belgium, Bulgaria, Chile, Columbia, Czech Republic, Dominican Republic, Egypt, Finland, France, Germany, Greece, Hungary, Italy, Lithuania, Malaysia, Mexico, Norway, Pakistan, Poland, Portugal, Russia, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Arab Emirates, United Kingdom, Venezuela.
Lot / Code Info
Single Pack - Outer Box UPN H7493893103J0, Inner Pouch UPN H7493893103J0 with the following Outer Box Batch number / Inner Pouch Batch number: 8447584/8424370; 8541995/8510188; 8544020/8510187; 8577183/8503242; 8577293/8503244; 8577534/8333665; 8579728/8418259; 8580421/8406879; 8580887/8475378; 8580917/8475377; 8581079/8530796; 8585386/8503269; 8587755/8503243; 8588197/8503270; 8588877/8388791; 8591438/8376779; 8592293/8418258; 8592533/8414114; 8593589/8559710; 8593596/8539572; 8594060/8559712; 8597428/8539574; 8597830/8556834; 8598870/8388789; 8600066/8559711; 8600420/8564504; 8602812/8564506; 8603659/8567100; 8606749/8389080; 8606923/8567101; 8607935/8579186; 8607935/8556836; 8608015/8579186; 8614864/8580832; 8614869/8424371; 8615879/8567099; 8616669/8539573; 8620583/8596274; 8620754/8475382; 8628574/8596276; 8628912/8580831; 8630440/8596275; 8636284/8602641; 8636415/8602640; 8649768/8607727; 8650600/8602642; 8652901/8607728; 8654225/8602643; 8654227/8607725; 8670952/8530791; 8676700/8635975; 8685522/8649203; 8690104/8635973; 8698011/8635340; 8698012/8635972; 8698293/8653545; 8699510/8635341; 8699989/8530668; 8701815/8635976; 8702228/8530797; 8710305/8556838; 8711647/8649204; 8711691/8653546; 8711815/8661235; 8712096/8665816; 8712099/8530790; 8716342/8653547; 8722177/8683665; 8722191/8693297; 8722301/8665815; 8730052/8665814; 8731234/8695647; 8733364/8683670; 8734071/8691635; 8740494/8687514; 8741462/8661234; 8745691/8687516; 8748547/8693296; 8749063/8695649; 8750426/8708960; 8753228/8683668; 8754548/8693298; 8758129/8708968; 8758432/8719088; 8759720/8691637; 8764914/8721351; 8766444/8721352; 8766905/8708969; 8769690/8718984; 8769944/8695646; 8773040/8708966; 8773153/8691639; 8775975/8719089; 8776994/8744947; 8783863/8708965; 8784103/8708958; 8784392/8756635; 8785597/8756634; 8788048/8687515; 8789999/8760871; 8793576/8743903; 8794952/8767167; 8797558/8744946; 8798246/8760865; 8800605/8760864; 8801108/8744945. 5-pack - Outer Box UPN H7493893103J2, Inner Pouch UPN H7493893103J0 with the following Outer Box Batch number / Inner Pouch Batch number: 8447685/8424370; 8541998/8510188; 8544019/8510187; 8577096/8475380; 8577182/8503242; 8577294/8503244; 8577535/8333665; 8580409/8418259; 8580422/8406879; 8580888/8475378; 8580918/8475377; 8581080/8530796; 8592294/8418258; 8592534/8414114; 8593591/8559710; 8593597/8539572; 8594061/8559712; 8597829/8539574; 8597831/8556834; 8598871/8388789; 8600065/8559711; 8602822/8564506; 8603658/8567100; 8606831/8389080; 8606924/8567101; 8607936/8579186; 8607936/8556836; 8608018/8579186; 8614865/8580832; 8615130/8424371; 8615880/8567099; 8616668/8539573; 8617431/8580830; 8620755/8475382; 8630441/8596275; 8636285/8602641; 8636416/8602640; 8640730/8596273; 8649767/8607727; 8650599/8602642; 8652900/8607728; 8654224/8602643; 8654226/8607725; 8676701/8635975; 8677779/8635342; 8698294/8653545; 8699851/8635341; 8699990/8530668; 8701816/8635976; 8702229/8530797; 8711692/8653546; 8711816/8661235; 8712098/8665816; 8712100/8530790; 8716343/8653547; 8722178/8683665; 8722302/8665815; 8722332/8693297; 8731237/8695647; 8733366/8683670; 8734132/8691635; 8740495/8687514; 8741463/8661234; 8748549/8693296; 8749065/8695649; 8750427/8708960; 8753229/8683668; 8754545/8708967; 8754549/8693298; 8758131/8708968; 8758433/8719088; 8759722/8691637; 8764915/8721351; 8766445/8721352; 8773154/8691639; 8774030/8743905; 8775976/8719089; 8776995/8744947; 8779683/8743904; 8783864/8708965; 8784104/8708958; 8784393/8756635; 8785598/8756634; 8788047/8687515; 8793578/8743903; 8794953/8767167; 8797559/8744946; 8798247/8760865; 8800606/8760864; 8801109/8744945.
Root Cause
Other
Action Taken
An Urgent Medical Device Recall letter, dated 08/31/06, was sent to affected customers. The letter describes the issue,states that distribution or use of affected product should cease immediately and replacement product will be issued for all returned devices. A Reply Verification Tracking Form is asked to be completed and returned to Boston Scientific.