Cardinal Health

SSI-0034 with LOT# 462799 & 476803  10-1100 with LOT# 462788 & 485406

Obstetrical and Gynecological Devices

2

No

Nationwide Distribution including AR, KS, WV, , NC, TX, AL, MS and VA.

Gomco Style Circumcision Clamp Trays is an instrument used to compress the foreskin of the penis during circumcision of a male infant.

Catalog number PMII, lot numbers RBE609, expiration date 1/07, and RJJ130, expiration date 7/07  Note: any box with an orange dot on the end of the box is suspected counterfeit product, regardless of lot number.

General and Plastic Surgery Devices

2

Yes

Nationwide

Prolene Polyproplyene Mesh, 3'' x 6'', Nonabsorbable Synthetic Surgical Mesh; six packages per box; sterile; product code PMII; Ethicon Inc., Somerville, NJ 08876

all recent lots of the following kit catalog numbers PB53VDOCF, PB54ADSNO, PBCGCSEZC, PBCGDKEZC, PBHFVDLRG, PBVBSCNMK, PC21OHHOF, PC43CCLGC, PC43OH79D, PECGCL16M, PECGET16D, PEOCMEBL1, PEOCMEBLD, PEVTCESWV, PG69VSUS1, PG69VSUSF, PGCGOTUI8, PH76OTMDS, PH76TCMDR, PL23CSAML, PL23VDMPY, PL29OTRMU, PL41CSHSO, PL41VD16I, PL41VD87F, PL42VGTMG, PL42VGTMH, PL42VGTMI, PL54OTSMG, PL57DVSCI, PL57SCSCG, PL73CSSJU, PL73FBDWC, PL81CS99M, PL81VDSFX, PL8FCSSVA,  PL8FVDSVB, PLCGLR52A, PLCGOTMJU, PLCGVD66B,  PLCNCSHSW, PLCNLRLVU, PLVBCSSFR, PLVQMBPAD,  PN46CRKMA, PN48NNCHB, PNCGSPCDR, PNOCCRBLF,  PNVMCFBHG, PNVMCRBHM, PP15ICFCK, PPOCLGBSN,  PU40TRSOJ, PUOCOTSO1, PW82BSTCQ, PZ15LRFCC,  PZ51BCA701, PZ51BCA70C, PZMHADFBH, PZMHNAKYG,  PZOCADBSD, PZOCADFRB, PZOCBCGVD, PZVBOTANMS,  PZVZOTMIE, SAM55AMQMC, SAN12MPWCD, SAN21MYHOD,  SAN23AGDHC, SAN23ANDHF, SAN26BTACB, SAN31PPELF,  SAN48CCCHP, SANHDMRUMA, SANHDPRPIA, SBA13BNMGC, SBA13BNMGD, SBA18LCSCJ, SBA24BBMMA, SBA33PMSMA, SBA33PMSMB, SBA44IRMDC, SBA4APEJHE, SBB32BBNMD, SBB32BBNME, SBB53BTEVD,  SBB55BBMMG, SCV19OHCH6, SCV22AOKMA, SCV43CVBRI,  SCV43OHMWQ, SCV44NUHWA, SCV51VCKKD, SCVHBHSTMC, SEN13ORBWK, SEN19BSFMF, SEN31NSLUQ, SEN31PPLUK, SEN31PPNMA, SEN31TALUP, SEN31THLUR, SEN51HDKKD, SEN5CEPGSC, SID51STKKA, SMA32EAHSA, SMA33EACBC, SNE11PMDO2, SNE11PMDOB, SNE12EPNEA, SNE19CRCHU, SNE32CPSV1, SNE32CPSVC, SNE32CPSVE, SNE32CPSVF, SNE35LFBHB, SNE35LMBHI, SNE36STWPH, SNE48LPWLC, SNE51LMKKG, SNU23BSCHF, SNU42BSNKC, SOP21BSDKC, SRI63ACUMC, SRIGS0049M, SRINU0546N, SRINU0546O, SRINU0866J, SRIOR0870H, SRIOR0870I, SRIOR0871K, SRIOR0871L, UMA24CE43T, UMA24VA439 and UMA24VA43S

General and Plastic Surgery Devices

2

No

Nationwide Distribution including California, Florida, Illinois, Kentucky, Minnesota, Missouri, Ohio, Tennessee, Washington, West Virginia and Wisconsin

Presource Custom Sterile Surgical and Procedure Kits; general surgery trays; Cardinal Health, McGaw Park, IL 60085; The kit catalog numbers listed in the code information section below contain one or more of the following listed components for which Cardinal Health has been unable to confirm the manufacturer's compliance with section 502(o) of the FD&C; Act: || a) 24" Infant Tape Measure, component 30942P; || b) Silicone Tubing, component SFM3-4450; || c) Triple Dye Drug, 10 unit dose, component PM1022; || d) Assembly Swabstick, component PS004; || e) 18x26 Poly Lined Towel, component 8580Z; || f) Disposable Vein Stripper, component 63-0431; || g) Cotton Glove, Large, White, PR, NS, component 1051; || h) Cotton Glove, Medium, White, PR, NS, component 1051M; || i) 6 Inch Metric-Inch Ruler, component 18C-Thru; || The kits are custom packed with all of the specific disposable class 1 and 2 devices required by the customer for specific types of surgery and medical procedures. These packs are then sterilized and are ready to be used by the customer for the specific procedure.

all recent lots of the following kit catalog numbers 03-2503F 03-2503H, 03B5615C, 4628, BA3CG4740K, BAB239109A, BAB920079C, MA1567670P, MA2CG6972D, MAN21ATAMC, MAT453740O and MATW11527D

General and Plastic Surgery Devices

1

No

Nationwide Distribution including California, Florida, Illinois, Kentucky, Minnesota, Missouri, Ohio, Tennessee, Washington, West Virginia and Wisconsin

Presource Custom Sterile Surgical and Procedure Kits; surgical trays; Cardinal Health, McGaw Park, IL 60085; The kit catalog numbers listed in the code information section below contain one or more of the following listed components for which Cardinal Health has been unable to confirm the manufacturer's compliance with section 502(o) of the FD&C; Act: || a) Adhesive Remover Wipes, component 050-0415; || b) Perineze Perineal Witch Hazel Pad, component 505040A || c) 24" Infant Tape Measure, component 30942P; || d) Triple Dye Drug, 10 unit dose, component PM1022; || The kits are custom packed with all of the specific disposable class 1 and 2 devices required by the customer for specific types of surgery and medical procedures. These packs are then sterilized and are ready to be used by the customer for the specific procedure.

Catalog #9158: lot numbers 06FRD326, 06FRD341, 06GRD006, 06GRD013 and 06HRD110;  Catalog #9158CE: lot numbers 06FAD344, 06FAD370, 06FAD405, 06HAD109

General Hospital and Personal Use Devices

2

No

Worldwide Distribution- USA and countries of Kuwait and Australia

Convertors Tiburon Cardiovascular Split Drape II, Sterile, for single use only; Cardinal Health, McGaw Park, IL 60085-6787, Made in Mexico || The cardiovascular drapes were packagaged under the following configurations: || a) Catalog #9158 - 1 CV split drape || b) Catalog #9158CE - 8 x 1 CV split drape