Events

Recall of Cardinal Health Sterile Presource PBDS Modules

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cardinal Health.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    36421
  • Event Risk Class
    Class 2
  • Event Number
    Z-0062-2007
  • Event Date Posted
    2006-10-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-05-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48729
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Drape - Product Code LRO
  • Reason
    The cardiovascular drape may tear and/or fray at the reinforced fenestrated trough area during use.
  • Action
    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.

Device

Cardinal Health Sterile Presource PBDS Modules
  • Model / Serial
    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
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution- USA and countries of Kuwait and Australia
  • Product Description
    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
  • Manufacturer
    Cardinal Health

Manufacturer

Cardinal Health
  • Manufacturer Address
    Cardinal Health, 1430 Waukegan Rd, Mc Gaw Park IL 60085-6726
  • Manufacturer Parent Company (2017)
    Cardinal Health
  • Source
    USFDA