—#48729

Product

Cardinal Health Sterile Presource PBDS Modules, have Presource Custom Sterile Packs containing the Cardiovascular Split Drape II or a Sterile Convertors Tiburon Cardiovascular Split Drape II bundled in the module; packaged by Cardinal Health Medical Products and Services, McGaw Park, IL 60085; identified by the following catalog numbers: PBDS modules containing catalog 9158: a) PC40OHRJR - Basic Open Heart Kit, RWJ; b) PC40OHRJT - Basic Open Heart Kit, RWJ; PBDS modules containing custom sterile packs: a) PWOCBSBSE - Breast Reduction Kit, pack SBA13BRBSE; b) PC40CGSLK - CABG Kit, ***, pack SCV11CESLB; c) PCOCCGNYO - CABG Kit, ***, pack SCV11OCNYN; d) PCOCOHNME - Open Heart Kit, pack SCV11OHNMC; e) PC40VPSLD - Valve Kit, pack SCV11VASLB; f) PC78OHUVZ - Open Heart Kit, ***, pack SCV56CH11A; g) PC82OH16C - Open Heart Kit, ***, pack SCV59MJTCW; h) PC82OH17O - Open Heart Kit, pack SCV69OH17E; i) PCVROHDMI - Open Heart Kit, pack SCV53HTDMG; j) PC15CGFCL - CABG Kit, ***, pack SCV32CPMUO; k) PCOCOHLLD - Open Heart Kit - Adult, pack SCV11ADLLD; l) PG15OTFCI - General Surgery Kit, Fairview, pack SBA32GSMUL; m) PGCGLRLUP - Liver Transplant Kit 747340, pack SBA31LVLUM; n) PC13OHEMR - Open Heart Adult Pk Kit, pack SCV13AMEMJ; o) PC60CJICX - Cardiac Major Kit, pack SCV11CJICL; p) PCOCOHMMK - Open Heart AB Kit, ***, pack SCV11HEMMI; q) PCV2CG34A - G 3 CABG Kit, ***, pack SCV11CBNYP; r) PCV2CP10J - CABG Kit, ***, pack SCV11CGCPR; s) PCV2VRNHW - G 3 Valve Kit, ***, pack SCV11VLNYM; t) PVOCAA76F - AAA Kit, ***, pack SCV13AABSV u) UCV42OPVC3 - *** Open Heart Kit, pack SCV42OPVCG; v) PC92CBHRB - *** CABG 2 of 2 Kit, pack SCV92CBHRB; w) PC44CGDEB - *** CV Kit, pack SCV44CVDEB; x) PC22OHMHW - *** Open Heart Kit, pack SCV22OHMES; y) PC23OPSFH - *** Open Heart Kit, pack SCV23AOSFH; z) PC43OHHRG - *** Open Heart Kit, pack SCV43OHHRF; aa) PV24CAGME - *** CABG Kit, pack SCV24CAGME; bb) PC40OHTJI - Open Heart Kit, pack SCV11MJTJI

FDA product code: LRO — General Surgery Tray
Device class: Class 2
Medical specialty: General, Plastic Surgery
Affected lot / code info: cat #PC40OHRJR, order #10054217, 10055120, 10057934; cat #PC40OHRJT, order #10065291, 10077187; cat #PWOCBSBSE, order #10060748; cat #PC40CGSLK, order #10061804, 10066623; cat #PCOCCGNYO, order #10065587; cat #PCOCOHNME, order #10065687; cat #PC40VPSLD, order #10043999; cat #PC78OHUVZ, order #10060807, 10069028; cat #PC82OH16C, order #10068824; cat #PC82OH17O, order #10052174, 10054524, 10065426, 10065686; cat #PCVROHDMI, order #10057971; cat # PC15CGFCL, order #10064101; cat #PCOCOHLLD, order #10065095; cat #PG15OTFCI, order #10067619; cat #PGCGLRLUP, order #10062174, 10068393; cat #PC13OHEMR, order #10063121, 10070917; cat #PC60CJICX, order #10067310; cat #PCOCOHMMK, order #10055151, 10066811; cat #PCV2CG34A, order #10047446; cat #PCV2CP10J, order #10062941; cat #PCV2VRNHW, order #10047450; cat #PVOCAA76F, order #10066307; cat #UCV42OPVC3, order #774231; cat #PC92CBHRB, order #776785; cat #PC44CGDEB, order #780376; cat #PC22OHMHW, order #731809; cat #PC23OPSFH, order #737659; cat #PC43OHHRG, order #739410; cat #PV24CAGME, order #740765; cat #PC40OHTJ1, order #10075965

Why it was recalled

The cardiovascular drape may tear and/or fray at the reinforced fenestrated trough area during use.

Root cause (FDA determination)

Other

Action the firm took

Cardinal Health sent separate recall letters dated 9/27/06 via UPS next day delivery to those accounts who ordered the drapes alone and those accounts who ordered custom sterile packs and PBDS modules, informing them that the cardiovascular split drapes may tear and/or fray at the reinforced fenestrated trough area during use. The letters listed the catalog numbers and affected lot numbers of the sterile drapes, and the letters sent to the pack and module customers were accompanied by a listing of catalog numbers and work order numbers for the affected packs ordered by each account. The accounts were requested to inspect their inventory to determine if they had any of the affected product on hand; segregate the affected inventories; complete and return via fax at 847-689-9101, the enclosed acknowledgment form, indicating the number of drapes in inventory being destroyed; and contact the El Paso Customer Service Center at 915-779-3681 to order replacement product. Distributors were requested to notify their customers of the recall. An additional letter dated 10/25/06 was sent via UPS overnight delivery to 49 of the accounts, expanding the recall to include lot 06HRD110 of catalog #9158, Convertors Tiburon Cardiovascular Split Drape II, Sterile. The instructions remained the same as those in the 9/27/06 letter.

Recalling firm

Firm: Cardinal Health
Address: 1430 Waukegan Rd, Mc Gaw Park, Illinois 60085-6726

Distribution

Distribution pattern: Worldwide Distribution- USA and countries of Kuwait and Australia

Timeline

Recall initiated: 2006-09-27
Posted by FDA: 2006-10-21
Terminated: 2008-05-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #48729. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.