Recall record at a glance
| Official record | Z-0964-2019 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | American Contract Systems, Inc. |
| Report date | Mar 6, 2019 |
| Recall initiation date | Nov 21, 2018 |
| Quantity | 51,152 units total |
| Location | Bloomington, MN, United States |
Official product description
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
Why the product was recalled
Potential that product has not reached complete sterilization,
Distribution information
US Distribution is to Florida.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Telephone.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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