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Z-0964-2019Class II

Bag size #4 Custom Convenience Kits Usage: Surgical convenience kits labeled as the following: a. Tray Name...

American Contract Systems, Inc. / initiated 2018-11-21 / Terminated / root cause: manufacturing process
FDA source (opens on fda.gov)

American Contract Systems, Inc. began a recall of 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... on . FDA classified it as Class II and gives the reason as "Potential that product has not reached complete sterilization". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-0964-2019
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
American Contract Systems, Inc.
Product
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
Product code
FYA Gown, Surgical
Reason for recall
Potential that product has not reached complete sterilization,
Root cause tag
manufacturing process
FDA root cause
Process control
Action
ACS notified their customer on 11/21/2018, via telephone call. The customer was questioned if they had any packs on their shelf from November 2016 through October 2017. On 12/03/2018 their customer was notified via "RECALL" letter sent via email. The letter instructed their customer to notify appropriate individuals within their organization of the recall, examine inventory for affected devices, and quarantine and discontinue use of any affected devices. The customer was also instructed to complete and return the RECALLED PRODUCT RETURN FORM via mail to: LeeSar 2727 Winkler Avenue Fort Myers, FL 33901, email: [email protected] or fax to: 239-939-6519. If you have any questions, contact Quality Assurance Manager at 952-967-2663 or email: [email protected].
Quantity in commerce
51,152 units total
Distribution
US Distribution is to Florida.
Product codes and lots
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)

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0964-2019
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0964-2019Class IITerminatedVoluntary: Firm initiated