Reported Mar 6, 2019 · Terminated
Bag size #4 Custom Convenience Kits Usage
American Contract Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: American Contract Systems, Inc. · 4801 W. 81st St. · Bloomington, MN · 55437
Is this the product you have?
Bag size #4 Custom Convenience Kits Usage
26 of 26 products
| # | Product as published |
|---|---|
| 1 | Tray Name: PACK BASIC SET UP LH - 2035102, Tray Number: LSRBASICPACD |
| 2 | Tray Name: PACK ANGIOGRAM CFH - 2071297, Tray Number: LSRCFHANGD |
| 3 | Tray Name: PACK BASIC VIII CFH - 2073903, Tray Number: LSRCFBVIIIPKE |
| 4 | Tray Name: PACK BASIC VIII CFH -2072667, Tray Number: LSRCFBVIIIPKD |
| 5 | Tray Name: PACK BREAST GARRAMONE, Tray Number: LSRGABRSB |
| 6 | Tray Name: PACK CARDIAC CATH LH - 2073653, Tray Numbers: LSRCARDCATHF, LSRCFHCATHE |
| 7 | Tray Name: PACK CAROTID CFH - 2022261, Tray Number: LSRCFHCARC |
| 8 | Tray Name: PACK CAROTID CFH - 2070082, Tray Number: LSRCFHCARD |
| 9 | Tray Name: PACK CATH PACK CFH - 2065429, Tray Number: LSRCFHCATHD |
| 10 | Tray Name: PACK CYSTO-TUR CFH - 2066423, Tray Number: LSRCFHCYTURC |
| 11 | Tray Name: PACK D-C GYN CFH - 2023208, Tray Number: LSRCFHDCGYNC |
| 12 | Tray Name: PACK D-C LH - 2067690, Tray Number: LSRLMDCA |
| 13 | Tray Name: PACK EENT CFH - 2023005, Tray Number: LSRCFENTB |
| 14 | Tray Name: PACK EENT CFH - 2073904, Tray Number: LSRCFENTC |
| 15 | Tray Name: PACK ENDOSCOPIC LH - 2073429, Tray Numbers: LSRENDOSCOPG, LSRENDOSCOPH |
| 16 | Tray Name: PACK ENDOVENOUS LH - 2072299, Tray Number: LSRLMENDOVB |
| 17 | Tray Name: PACK GENERIC A - 2018972, Tray Number: LSRMISCA |
| 18 | Tray Name: PACK HP GYN LAPAROSCOPY LH -2067955, Tray Number: LSRHPGYND |
| 19 | Tray Name: PACK KNEE ARTHROSCOPY SMHS - 2065237, Tray Number: LSRKNEEARTHF |
| 20 | Tray Name: PACK OCCULAR DRAPE LH - 2034766, Tray Number: LSROCCULARC |
- Lot codes and dates
26 of 26 products
Products covered by this recall # Product as published 1 Tray Number: LSRBASICPACD (1610281, 1611301, 1701041, 1701301, 1702111, 1702201, 1703171, 1703232, 1704101, 1705052, 1705061, 1705092, 1705252, 1706141, 1707101, 1708041, 1708291, 1710132) 2 Tray Number: LSRCFHANGD (1611091, 1701052, 1702232, 1703141, 1705082, 1705101, 1707071, 1708301) 3 Tray Number: LSRCFBVIIIPKE (1709071/2) 4 Tray Number: LSRCFBVIIIPKD (1612021, 1701251, 1703142, 1704111, 1705241, 1707171, 1708071) 5 Tray Number: LSRGABRSB (1701112, 1703101, 1704271, 1706082, 1708112) 6 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) 7 Tray Number: LSRCFHCARC (1611111, 1701101, 1702272, 1705012, 1706201, 1707221) 8 Tray Number: LSRCFHCARD (1709061, 1710241) 9 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) 10 Tray Number: LSRCFHCYTURC (1611181, 1702062, 1702141, 1703151, 1704262, 1705171, 1706261, 1707171, 1708142, 1709052, 1710271) 11 Tray Number: LSRCFHDCGYNC (1611032, 1701281, 1703221, 1705012, 1706081, 1707221, 1709292) 12 Tray Number: LSRLMDCA (1611071, 1702081, 1704192, 1707241, 1710091) 13 Tray Number: LSRCFENTB (1611031, 1612162, 1701231, 1703081, 1704291, 1706121, 1707201) 14 Tray Number: LSRCFENTC (1708231) 15 Tray Numbers: LSRENDOSCOPG (1611041, 1701041, 1702151), LSRENDOSCOPH (1703301, 1705051/2, 1706061, 1707032, 1708011, 1709061, 1710271) 16 Tray Number: LSRLMENDOVB (1611021, 1703062, 1703292, 1704271, 1705091, 1708251) 17 Tray Number: LSRMISCA (1702181) 18 Tray Number: LSRHPGYND (1611071, 1612211, 1702092, 1704061, 1705102, 1706161, 1707201, 1709191) 19 Tray Number: LSRKNEEARTHF (1611291, 1612241, 1702141, 1703081, 1704182, 1705171, 1707062, 1708182) 20 Tray Number: LSROCCULARC (1611171, 1703152, 1705052, 1708042) - Amount recalled
- 51,152 units total
Where it was sold
Why it was recalled
Potential that product has not reached complete sterilization,
This product could cause temporary or reversible health problems — stop using it.
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