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U.S. Department of Health and Human Services

Class 2 Device Recall PeriStrips Dry Staple Line Reinforcement with Apex Processing (PSD) and PeriStrips Dry with Verita

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 Class 2 Recall
PeriStrips Dry Staple Line Reinforcement with Apex Processing (PSD) and PeriStrips Dry with Verita
see related information
Date Posted September 21, 2010
Recall Status1 Terminated on December 17, 2011
Recall Number Z-2447-2010
Recall Event ID 56327
Premarket Notification
510(K) Numbers
K040415  K041669 
Product Classification Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene - Product Code DXZ
Product PSD Gel that's provided with Peri-Strips Dry Staple Line Reinforcement with Apex Processing (PSD) and Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement (PSD-V) products. Sterile, Rx only, Synovis® Surgical Innovations. Intended to be used as a staple line buttress.
Code Information Petri Strips Model and Lot #'s: Model Lot PSD 4506-ECH-V 5760747-1306827 PSD 4506-ECH-V 5761913-1306839 PSD 4506-U-V 5762171-1306780 PSD 6006-ECH-V 5766878-1300372 PSD 6006-U-V 5766879-1300375 PSD 6006-ECH-V 5766880-1300376 PSD 5506-E-V 5766886-1300401 PSD 4506-UN 5766893-1300461 PSD 4506-ECH-V 5766900-1300468 PSD 6006-ECH-V 5766913-1300541 PSD 6006-ECH-V 5766913-1300542 PSD Gel 3 pk w Tips 5766915-1300544 PSD 6006-ECHN 5766916-1300573 PSD 6002-ECHN 5766917-1300574 PSD 6006-U-V 5766921-1300877 PSD 4506-ETSN 5766936-1300903 PSD 6006-U-V 5766941-1300912 PSD 6006-UN 5766947-1301133 PSD 6006-UN 5766947-1301134 PSD 6006-UN 5766947-1301135 PSD 4506-EN 5766969-1301567 PSD 7502-EN 5766970-1301568 PSD 6006-ETS-V 5766971-1301569 PSD 4506-U-V 5766972-1301571 PSD 4506-U-V 5766972-1301572 PSD 8006-U-V 5766991-1301680 PSD 4506-ETS-V 5766994-1301723 PSD 6006-ECH-V 5766996-1301728 PSD 6006-ECH-V 5766997-1301729 PSD 6006-ECH-V 5766998-1301730 PSD 4506-ETS-V 5766999-1301731 PSD 4506-ETS-V 5767049-1302412 PSD 4506-ETSN 5767051-1302478 PSD 6006-U-V 5767052-1302479 PSD 6006-ECH-V 5767053-1302482 PSD 4506-ECH-V 5767065-1302822 PSD 7506-E-V 5767066-1302830 PSD 6006-U-V 5767084-1302970 PSD 6006-U-V 5767084-1302971 PSD 6006-ECH-V 5767085-1302972 PSD 6006-ECH-V 5767103-1303307 PSD 6006-ECH-V 5767104-1303308 PSD 5506-EN 5767116-1303323 PSD 6006-ECH-V 5767124-1303426 PSD 6006-ECH-V 5767125-1303427 PSD 4506-UN 5767154-1303759 PSD 7506-EN 5767155-1303760 PSD 6006-ECH-V 5767168-1303787 PSD 4502-ETSN 5767169-1303841 PSD 6006-U-V 5767171-1303870 PSD 4506-ETS-V 5767196-1304197 PSD 6006-ECH-V 5767198-1304199 PSD 6006-U-V 5767247-1304249 PSD 6006-U-V 5767247-1304250 PSD 6006-ECH-V 5767270-1305009 PSD 6006-ECH-V 5767270-1305010 PSD 6006-ECH-V 5767270-1305011 PSD 6006-ECH-V 5767270-1305012 PSD 6006-U-V 5767271-1305013 PSD 8006-U-V 5767274-1305043 PSD 6006-ECH-V 5767275-1305046 PSD 6006-ECH-V 5767276-1305047 PSD 6006-ECHN 5767300-1305173 PSD 6006-ECHN 5767300-1305175 PSD 4506-EN 5767314-1305515 PSD 4506-U-V 5767315-1305516 PSD 6006-ECH-V 5767316-1305517 PSD 6006-ECH-V 5767316-1305518 PSD 6006-ECH-V 5767317-1305519 PSD 6006-ECH-V 5767360-1305998 PSD 6006-ECH-V 5767361-1305999 PSD 6006-U-V 5767362-1306000 PSD 4506-ECHN 5767376-1306051 PSD 6006-U-DST-V 5767386-1306181 PSD 6006-ETS-V 5767388-1306184 PSD 7502-EN 5767432-1306692 PSD 7502-EN 5767432-1306693 PSD 6006-U-V 5767433-1306694 PSD 7506-EN 5767440-1306768 PSD 8006-UN 5767459-1306848 PSD 6006-UN 5767468-1307175 PSD 6006-UN 5767468-1307176 PSD 6006-ECH-V 5767504-1308129 PSD 7506-E-V 5767507-1308132 PSD 10006-E-V 5767508-1308133 PSD 8006-UN 5767539-1308363 PSD 6006-ECH-V 5767548-1308658 PSD 7506-E-V 5767558-1308672 PSD 6006-UN 5767634-1309218 PSD 6006-ECH-V 5767637-1309222 PSD 6002-ECH-V 5767674-1310099 PSD 6002-ECH-V 5767674-1310100 PSD 6002-ECH-V 5767674-1310101 PSD 6002-ECH-V 5767674-1310102 PSD 6002-ECH-V 5767674-1310103 PSD 6002-ECH-V 5767674-1310104 PSD 6002-ECH-V 5767674-1310106 PSD 6002-ECH-V 5767674-1310107 PSD 6002-ECH-V 5767674-1310108 PSD 6002-ECH-V 5767674-1310109 PSD 6002-ECH-V 5767674-1310110 PSD 6002-ECH-V 5767674-1310111 PSD 6002-ECH-V 5767674-1310112 PSD 6002-ECH-V 5767674-1310113 PSD 6002-ECH-V 5767674-1310114 PSD 6002-ECH-V 5767674-1310115 PSD 6006-U-DST-V 5767731-1311054 PSD 6006-ECH-V 5767735-1311082 PSD 6006-U-V 5767791-1311823 PSD 6002-ECHN 5767839-1312956 PSD 6002-ECH-V 5767840-1312958 PSD 7502-EN 5767899-1314266 PSD 6006-UN 5767901-1314269 PSD 6006-UN 5767903-1314271 PSD 6006-U-V 5767927-1316667 PSD 4506-U-V 5768012-1317865 PSD 9006-U-V 5768074-1318704 PSD 9006-U-V 5768074-1318705 PSD 6006-ECHN 5768075-1318721 PSD 8006-U-V 5768212-1321931 Gel Lot #'s 5765055-1270575 5765056-1270600 5765454-1276004 5765776-1283012 5765993-1286191
Recalling Firm/
Manufacturer
Synovis Surgical Inovation Div. of
2575 University Ave W
Saint Paul, Minnesota 55114-1073
Manufacturer Reason
for Recall
Synovis¿ Surgical Innovations is voluntarily recalling PSD Gel that's provided with Peri-Strips Dry Staple Line Reinforcement with Apex Processing (PSD) and Peri-Strips Dry with Veritas Collagen Matrix Staple line Reinforcement (PSD-V) products. Internal investigation have shown there is a potential for small defects in the PSD gel tube pouch which may compromise the sterility of the outside of t
FDA Determined
Cause 2
PRODUCTION CONTROLS: Packaging
Action Consignees were sent on 6/30/10 a Recall Notification letter dated June 30, 2010. The letter was addressed to "Risk Manager". The letter described the problem and product involved. They listed both the device and gel lot numbers since it is possible that some hospitals have separated the pouched gel tubes from the PSD/PSDV products. They advised consignees to quarantine the affected lots and to complete and fax the attached "Product Return/Replacement" form to Synovis Surgical Innovations.
Quantity in Commerce 3,989 gel tubes and 1,395 PSD & PSDV devices.
Distribution Worldwide Distribution -- USA, including states of AL, AZ, CA, CO, CT, DE, FL, GA, ID, IL,IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WV, and WI and countries of AUSTRALIA, GERMANY, GREECE, HONG KONG, NETHERLANDS, PUERTO RICO, ROMANIA, SAUDI ARABIA, SPAIN, SWEDEN, SWITZERLAND, and UNITED KINGDOM.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DXZ and Original Applicant = SYNOVIS SURGICAL INNOVATIONS
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