Events

Recall of Presource Custom Sterile Packs

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-0060-2007
  • 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=48718
  • 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

Presource Custom Sterile Packs
  • Model / Serial
    cat #SVC13AMEMK, order #777594;  cat #SCV31OHMPJ, order #773933;  cat #SVC42OPVCG, order #774231;  cat #SCV32CPMUO, order #774845;  cat #SCV34OHTMJ, order #775103;  cat #SCV31LVLUM, order #775646;  cat #SCV19CVHHF, order #776102;  cat #SCV11ADLLD, order #776475;  cat #SCV92CBHRB, order #776785;  cat #SCV92CASIA, order #776792;  cat #SBA32GSMUL, order #777047;  cat #SCV30OHKWA, order #777171;  cat #SBA31LVLUM, order #777288;  cat #SBA35LTBLQ, order #777599;  cat #SCV44CVDEB, order #780376;  cat #SCV22OHMES, order #731809;  cat #SCV23AOSFH, order #737659;  cat #SCV43OHHRF, order #739410;  cat #SCV24CAGME, order #740765;  cat #SAN12CCKGB, order #732285;  cat #SBA13BRBSE, order #731714;  cat #SCV11CBNYP, order #732629;  cat #SCV11CESLB, order #734779;  cat #SCV11CGCPR, order #732923;  cat #SCV11CGXXB, order #735832;  cat #SCV11CJICL, order #735189;  cat #SCV11CTMUK, order #734463;  cat #SCV11DPMYG, order #732152;  cat #SCV11HEMMI, order #733639;  cat #SCV11MRCPE, order #733157;  cat #SCV11OCNYN, order #732625;  cat #SCV11OHLD2, order #732191;  cat #SCV11OHNMC, order #732446;  cat #SCV11OPLKC, order #735134;  cat #SCV11VASLB, order #737823;  cat #SCV11VLNYM, order #732656;  cat #SCV12OHYHY, order #735934, 734739, 732575;  cat #SCV13AABSV, order #732913;  cat #SCV13AMEMJ, order #732970;  cat #SCV13BBEMC, order #732070;  cat #SCV13CB767, order #732869;  cat #SCV13OHCAI, order #733777, 731664;  cat #SCV13OOBIG, order #734407;  cat #SCV14O1BGO, order #738338;  cat #SCV22OHPGA, order #735643;  cat #SCV22OOMSE, order #738400;  cat #SCV24OH20A, order #735637;  cat #SCV43DREJI, order #741763;  cat #SCV69OH17E, order #975704;  cat #SCV59HVSGJ, order #975779;  cat #SCV59OHNVM, order #976192;  cat #SCV53HTDMG, order #976853;  cat #SCV56CH11A, order #977429;  cat #SCV59MJTCW, order #977839, 978730;  cat #SCV52OH97F, order #978285;  cat #SCV41OHHIE, order #978409;  cat #SCV52HTSJE, order #978410;  cat #SCV59OHMHV, order #978523; cat #SCV11MJTJI, order 737814
  • 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
    Presource Custom Sterile Packs containing the Cardiovascular Split Drape II; the custom sterile packs were packaged with the bulk, non-sterile drapes and then the complete custom pack was sterilized; packaged by Cardinal Health Medical Products and Services, McGaw Park, IL 60085; identified by the following catalog numbers: || a) SVC13AMEMK - Sterile Open Heart Adult Pk; || b) SCV31OHMPJ - Sterile Open Heart w Drapes Pk; || c) SVC42OPVCG - Sterile Open Heart Adult Pack; || d) SCV32CPMUO - Sterile CAB 146060 Pack; || e) SCV34OHTMJ - Sterile Basin Pack; || f) SCV31LVLUM - Sterile Liver Transplant Pack; || g) SCV19CVHHF - Sterile Cardiovascular Pack; || h) SCV11ADLLD - Sterile Open Heart/Adult; || i) SCV92CBHRB - Sterile CABG Pack; || j) SCV92CASIA - Sterile Cardiovascular Pack; || k) SBA32GSMUL - Sterile General Surgery Pack; || l) SCV30OHKWA - Strl **** Open Heart Pack; || m) SBA31LVLUM - Sterile Liver Transplant Pack; || n) SBA35LTBLQ - Sterile Lung Transplant Pack; || o) SCV44CVDEB - Sterile CV Pack; || p) SCV22OHMES - Open Heart Pack; || q) SCV23AOSFH - Open Heart Part 3; || r) SCV43OHHRF - Open Heart; || s) SCV24CAGME - CABG Drape Pack; || t) SAN12CCKGB - Cardiac Pack; || u) SBA13BRBSE - Breast Reduction; || v) SCV11CBNYP - CABG G 3; || w) SCV11CESLB - C.V. Drape Pack; || x) SCV11CGCPR - CABG; || y) SCV11CGXXB - CABG Pack; || z) SCV11CJICL - Cardiac Major; || aa) SCV11CTMUK - C T Set Up; || bb) SCV11DPMYG - **** S Drape Pack; || cc) SCV11HEMMI - Open Heart A B; || dd) SCV11MRCPE - Major Cardiac; || ee) SCV11OCNYN - OH CABG; || ff) SCV11OHLD2 - Open Heart A&B; Pack; || gg) SCV11OHNMC - Open Heart; || hh) SCV11OPLKC - O P CABG; || ii) SCV11VASLB - C V Valve Drape; || jj) SCV11VLNYM - G 3 Valve; || kk) SCV12OHYHY - Graft and Linen; || ll) SCV13AABSV - Aortic Aneurysm; || mm) SCV13AMEMJ - Open Heart Pack B; || nn) SCV13BBEMC - Cardio-Thoracic Aux; || oo) SCV13CB767 - CABG; || pp) SCV13OHCAI - Open Heart Pk; || qq) SCV13OOBIG - Open Heart Drape; || rr) SCV14O1BGO - Open Heart Pack A; || ss) SCV22OHPGA - Open Heart Pack; || tt) SCV22OOMSE - Open Heart Preferred; || uu) SCV24OH20A - Open Heart Drape Pack; || vv) SCV43DREJI - Open Heart Drape Pack; || ww) SCV69OH17E - Open Heart; || xx) SCV59HVSGJ - Heart Valve Pack; || yy) SCV59OHNVM - Open Heart Pack; || zz) SCV53HTDMG - ***** Open Heart; || aaa) SCV56CH11A - Open Heart Pack; || bbb) SCV59MJTCW - Open Heart Pack; || ccc) SCV52OH97F - Open Heart Pack; || ddd) SCV41OHHIE - Open Heart Pack; || eee) SCV52HTSJE - Open Heart Pack; || fff) SCV59OHMHV - Basic Heart Pack; || ggg) SCV11MJTJI - Open Heart
  • 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