FDA Enforcement Class II Terminated

Bag size #4 Custom Convenience Kits Usage: Surgical convenience kits labeled as the following: a. Tray Name: PACK BASIC SET UP LH - 2035102, Tray Number: LSRBASICPACD; b. Tray Name: PACK ANGIOGRAM CFH - 2071297, Tray Number: LSRCFHANGD; c. Tray Name: PACK BASIC VIII CFH - 2073903, Tray Number: LSRCFBVIIIPKE; d. Tray Name: PACK BASIC VIII CFH -2072667, Tray Number: LSRCFBVIIIPKD; e. Tray Name: PACK BREAST GARRAMONE, Tray Number: LSRGABRSB; f. Tray Name: PACK CARDIAC CATH LH - 2073653, Tray Numbers: LSRCARDCATHF, LSRCFHCATHE; g. Tray Name: PACK CAROTID CFH - 2022261, Tray Number: LSRCFHCARC; h. Tray Name: PACK CAROTID CFH - 2070082, Tray Number: LSRCFHCARD; i. Tray Name: PACK CATH PACK CFH - 2065429, Tray Number: LSRCFHCATHD; j. Tray Name: PACK CYSTO-TUR CFH - 2066423, Tray Number: LSRCFHCYTURC; k. Tray Name: PACK D-C GYN CFH - 2023208, Tray Number: LSRCFHDCGYNC; l. Tray Name: PACK D-C LH - 2067690, Tray Number: LSRLMDCA; m. Tray Name: PACK EENT CFH - 2023005, Tray Number: LSRCFENTB; n. Tray Name: PACK EENT CFH - 2073904, Tray Number: LSRCFENTC; o. Tray Name: PACK ENDOSCOPIC LH - 2073429, Tray Numbers: LSRENDOSCOPG, LSRENDOSCOPH; p. Tray Name: PACK ENDOVENOUS LH - 2072299, Tray Number: LSRLMENDOVB; q. Tray Name: PACK GENERIC A - 2018972, Tray Number: LSRMISCA; r. Tray Name: PACK HP GYN LAPAROSCOPY LH -2067955, Tray Number: LSRHPGYND; s. Tray Name: PACK KNEE ARTHROSCOPY SMHS - 2065237, Tray Number: LSRKNEEARTHF; t. Tray Name: PACK OCCULAR DRAPE LH - 2034766, Tray Number: LSROCCULARC; u. Tray Name: PACK OPHTHALMOLOGY LH - 2034932, Tray Number: LSROPHTHALD; v. Tray Name: PACK PICC LINE LH - 2008070, Tray Number: LSRPICCLINEG; w. Tray Name: PACK SHOULDER SMHS - 2065241, Tray Number: LSRSHOULDERD; x. Tray Name: PACK SINGLE BASIN LH - 2064837, Tray Number: LSRSINGLEBA; y. Tray Name: PACK STOCK PACEMAKER CFH - 2069578, Tray Number: LSRCFHPACRE; z. Tray Name: PACK VAGINAL DELIVERY SMHS - 2068301, Tray Number: LSRVAGDELIVC; aa. Tray Name: PACK CYSTO DECATUR - 2047265, Tray Number: LSRDECYSTA; bb. Tray Name: PACK MINOR DECATUR - 2071628, Tray Number: LSRDEMINB

Recall: Z-0964-2019 · Reported March 6, 2019

Enforcement

Recall Number: Z-0964-2019
Event ID: 81710
Classification: Class II
Status: Terminated
Product Type: Devices
Firm: American Contract Systems, Inc.
Voluntary / Mandated: Voluntary: Firm initiated
Initial Notification: Telephone
Report Date: March 6, 2019
Initiation Date: November 21, 2018
Classification Date: February 27, 2019
Termination Date: February 10, 2021
Address: 4801 W. 81st St., Bloomington, MN, 55437, United States

Description

Reason

Potential that product has not reached complete sterilization,

Code Info

Tray Number (Lot Number): a. Tray Number: LSRBASICPACD (1610281, 1611301, 1701041, 1701301, 1702111, 1702201, 1703171, 1703232, 1704101, 1705052, 1705061, 1705092, 1705252, 1706141, 1707101, 1708041, 1708291, 1710132); b. Tray Number: LSRCFHANGD (1611091, 1701052, 1702232, 1703141, 1705082, 1705101, 1707071, 1708301); c. Tray Number: LSRCFBVIIIPKE (1709071/2); d. Tray Number: LSRCFBVIIIPKD (1612021, 1701251, 1703142, 1704111, 1705241, 1707171, 1708071); e. Tray Number: LSRGABRSB (1701112, 1703101, 1704271, 1706082, 1708112); f. Tray Numbers: LSRCARDCATHF (1706271, 1707131, 1707241, 1708141, 1708311, 1710011, 1710031), LSRCFHCATHE (1610291, 1611281, 1612282, 1701231, 1702041, 1702071, 1703071, 1703202, 1703271, 1703301, 1704141, 1704192,1704282, 1705091, 1705182, 1705232, 1705312, 1706121); g. Tray Number: LSRCFHCARC (1611111, 1701101, 1702272, 1705012, 1706201, 1707221); h. Tray Number: LSRCFHCARD (1709061, 1710241); i. Tray Number: LSRCFHCATHD (1610312, 1611181, 1612301, 1701231, 1702032, 1702041, 1702081, 1702231, 1703162, 1704121, 1704261, 1705051, 1705161, 1705241, 1706082, 1706211, 1707101, 1707261, 1708151, 1709011, 1710052, 1710261); j. Tray Number: LSRCFHCYTURC (1611181, 1702062, 1702141, 1703151, 1704262, 1705171, 1706261, 1707171, 1708142, 1709052, 1710271); k. Tray Number: LSRCFHDCGYNC (1611032, 1701281, 1703221, 1705012, 1706081, 1707221, 1709292); l. Tray Number: LSRLMDCA (1611071, 1702081, 1704192, 1707241, 1710091); m. Tray Number: LSRCFENTB (1611031, 1612162, 1701231, 1703081, 1704291, 1706121, 1707201); n. Tray Number: LSRCFENTC (1708231); o. Tray Numbers: LSRENDOSCOPG (1611041, 1701041, 1702151), LSRENDOSCOPH (1703301, 1705051/2, 1706061, 1707032, 1708011, 1709061, 1710271); p. Tray Number: LSRLMENDOVB (1611021, 1703062, 1703292, 1704271, 1705091, 1708251); q. Tray Number: LSRMISCA (1702181); r. Tray Number: LSRHPGYND (1611071, 1612211, 1702092, 1704061, 1705102, 1706161, 1707201, 1709191); s. Tray Number: LSRKNEEARTHF (1611291, 1612241, 1702141, 1703081, 1704182, 1705171, 1707062, 1708182); t. Tray Number: LSROCCULARC (1611171, 1703152, 1705052, 1708042); u. Tray Number: LSROPHTHALD (1611021, 1701301, 1703292, 1707141); v. Tray Number: LSRPICCLINEG (1612212, 1702061, 1703151, 1704291, 1706131, 1707181, 1708311); w. Tray Number: LSRSHOULDERD (1611302, 1701131, 1702092, 1703082, 1704061, 1706031, 1708182); x. Tray Number: LSRSINGLEBA (1610261, 1611151, 1611221, 1612091, 1612232, 1701101, 1701172, 1701312, 1702022, 1702092, 1702111, 1702181, 1702231, 1703181, 1704011, 1704112, 1704191, 1704282, 1705011, 1705081, 1705181/2,1705221, 1705311,1706121, 1706141, 1706201, 1707071, 1707121, 1707171, 1707221, 1707271, 1708071, 1708101, 1708112, 1708141, 1708241, 1708312, 1709071, 1709201, 1710021, 1710122, 1710241); y. Tray Number: LSRCFHPACRE (1612191, 1702061, 1704251, 1704261, 1706151, 1707142, 1708181, 1710102); z. Tray Number: LSRVAGDELIVC (1612021, 1701251, 1703161, 1704242, 1706061, 1707032, 1708021, 1708172, 1709201); aa. Tray Number: LSRDECYSTA (1611091, 1611141, 1612211, 1702062, 1702141, 1703012, 1704182, 1705032, 1705171, 1709061, 1710181); bb. Tray Number: LSRDEMINB (1611111, 1612051, 1701311, 1703301, 1706011, 1706052, 1707071, 1707261, 1708171, 1709291)

Distribution

US Distribution is to Florida.

Quantity

51,152 units total