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Class 2 Device Recall Various Angiography packs/trays |
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| Date Initiated by Firm |
June 16, 2022 |
| Create Date |
September 08, 2022 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-1689-2022 |
| Recall Event ID |
90574 |
| Product Classification |
Angiography/angioplasty kit - Product Code OEQ
|
| Product |
Various Angiography packs/trays |
| Code Information |
Tray Number, Sterilization Lot, Lot Number, and Bag Serial Number:
1) LSRARTDATANGA,2105051, 884211, 44136929
2) LSRANGIRM21G,2105111, 874211, 63991913
3) LSRCFHANGD,2106031, 854211, 14887381
4) LSRARTDATANGA,2107102, 821211, 44256256
5) LSRARTDATANGA,2107102, 821211, 44256255
6) LSRARTDATANGA,2110011, 742211, 44373255
7) LSRARTDATANGA,2110011, 742211, 44373260
8) LMAN19U,2106292, 824211, 64169682
9) IHAN02S,2108111, 782211, 64190032
10) ANCA80AG,2109161, 743211, 64222813
11) SLPC34,2104022, 908211, 44127417-005
12) MHHY51F,2104151, 895211, 63978560-006
13) CXAN39N,2105072, 873211, 14875221-004
14) FHAG11X,2105072, 873211, 44111418-005
15) MHIR99AF,2105132, 868211, 63958625-006
16) BHAN91L,2105211, 860211, 44107976-005
17) ANCA80AG,2105212, 860211, 63956879-006
18) UDIN23AB,2105253, 855211, 63955146-006
19) SLPC34H,2106011, 853211, 44130251-005
20) SLPC34H,2106232, 827211, 43995487-005
21) SLPC34H,2106232, 827211, 43995488-005
22) FHAG11X,2106252, 825211, 43993760-005
23) FHAG11X,2106252, 825211, 44247863-005
24) SLPC34H,2107082, 817211, 44245946-005
25) CXAN39N,2107261, 793211, 15007653-004
26) CXAN39N,2107261, 793211, 15007652-004
27) UDCO10A,2107292, 790211, 64109977-006
28) BHAN91L,2107302, 789211, 44235082-005
29) FHAG11X,2108102, 778211, 44240799-005
30) FHAG11X,2108102, 778211, 44240798-005
31) BHAN91,2108131, 776211, 44240114-005
32) SLPC34H,2108242, 764211, 44315271-005
33) SLPC34H,2108242, 764211, 44315270-005
34) BHAN91L,2109101, 748211, 44320300-005
35) FHAG11X,2109151, 742211, 44318761-005
36) SLPC34H,2109232, 734211, 44316981-005
37) NCAG62G,2105252, 860211, 64063801-006
38) TMAN84F,2106162, 838211, 64044558-006
39) TMAN84F,2106162, 838211, 64044569-006
40) GSAN26D,2108131, 778211, 44216057-005
41) GSAN26D,2108131, 778211, 44215917-005
42) CGSP34G,2108271, 764211, 44336891-005
43) CGSP34G,2108271, 764211, 44336906-005
44) CGSP34G,2108271, 764211, 44336889-005
45) CGSP34G,2108271, 764211, 44336890-005
46) GSAN26D,2109271, 735211, 44353838-005
47) GSAN26D,2109271, 735211, 44353837-005
48) GSAN26D,2109271, 735211, 44353836-005
49) SJAR31F,2104211, 894211, 14702002-004
50) SJMY36D,2105241, 859211, 14894016-004
51) WHAI40C,2106071, 844211, 64133103-006
52) SSAR20D,2106151, 838211, 14893801-004
53) SJAR31F,2107191, 805211, 15031953-004
54) MPRM25D,2107261, 797211, 15028609-004
55) SJAR31F,2108231, 769211, 15025673-004
56) SJAR31F,2109141, 743211, 15023697-004
57) WHAI40C,2109241, 735211, 64135103-006
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Recalling Firm/
Manufacturer |
American Contract Systems, Inc.
2610 Ne Industrial Dr Ste 220
Kansas City MO 64117-2648
|
| For Additional Information Contact |
816-920-5846
|
Manufacturer Reason
for Recall |
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
|
FDA Determined
Cause 2 |
Process change control |
| Action |
The recalling firm began notifying customers of the recall beginning June 13, 2022. Customer notification was initially made via email and an "Urgent Medical Device Recall" letter dated June 16, 2022.
Customers are asked to review inventory and segregate affected product, which should be identified with the Bag Serial Number. Affected product should be destroyed, with evidence of destruction provided back to the recalling firm.
A Field Action Response Form should be completed and returned to angela.bunn@owens-minor.com as soon as possible, even if the customer has no inventory.
If you have any questions, please call 816-920-5846. |
| Quantity in Commerce |
57 units |
| Distribution |
Distribution within the United States to health systems and distributors in AZ, FL, IA, IL, MA, MN, MO, OH, NE, PA, RI, SD, and TX |
| Total Product Life Cycle |
TPLC Device Report
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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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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