Cardinal Health 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 steril Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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 steril
Brand
Cardinal Health
Lot Codes / Batch Numbers
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
Products Sold
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
Cardinal Health is recalling Cardinal Health Sterile Presource PBDS Modules, have Presource Custom Sterile Packs containing the C due to The cardiovascular drape may tear and/or fray at the reinforced fenestrated trough area during use.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The cardiovascular drape may tear and/or fray at the reinforced fenestrated trough area during use.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026