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U.S. Department of Health and Human Services

Class 2 Device Recall Surgical convenience kits

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  Class 2 Device Recall Surgical convenience kits see related information
Date Initiated by Firm November 21, 2018
Create Date February 27, 2019
Recall Status1 Terminated 3 on February 10, 2021
Recall Number Z-0964-2019
Recall Event ID 81710
Product Classification Gown, surgical - Product Code FYA
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
Code Information 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) 
Recalling Firm/
Manufacturer		 American Contract Systems, Inc.
4801 W. 81st St.
Bloomington MN 55437
For Additional Information Contact Tina Bakke
952-967-3515
Manufacturer Reason
for Recall		 Potential that product has not reached complete sterilization,
FDA Determined
Cause 2		 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: Allison.flood@leesar.com or fax to: 239-939-6519. If you have any questions, contact Quality Assurance Manager at 952-967-2663 or email: tbakke@amconsys.com.
Quantity in Commerce 51,152 units total
Distribution US Distribution is to Florida.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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