Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81710

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 21, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
American Contract Systems, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-0964-2019
Recall number
Z-0964-2019
Initiated
November 21, 2018
Classification
Class II
Status
Terminated
Quantity
51,152 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential that product has not reached complete sterilization,

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential that product has not reached complete sterilization,

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)

Distribution pattern

US Distribution is to Florida.