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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-1690-2022 |
| Recall Event ID |
90574 |
| Product Classification |
Cardiac catheterization kit - Product Code OES
|
| Product |
Various Angiography/Cath Lab packs/trays |
| Code Information |
Tray Number, Sterilization Lot, Lot Number, Bag Serial Number
1) LSRCUSTCATHG,2104091, 911211, 44064504
2) LSRCARDCATHG,2105191, 874211, 14884701
3) LSRCARDCATHG,2106031, 861211, 14887382
4) LSRCFHCATHD,2106151, 839211, 14887387
5) LSRCARDCATHG,2106172, 842211, 14882944
6) LSRCARDCATHG,2106172, 842211, 14887386
7) LSRCUSTCATHG,2106181, 840211, 44251069
8) LSRCFHCATHD,2107102, 810211, 15020227
9) LSRCFHCATHD,2107102, 810211, 15020826
10) LSRCFHCATHD,2107262, 807211, 15020266
11) LSRSPECPROCF,2107262, 803211, 64117654
12) LSRCARDCATHG,2108171, 783211, 44139783
13) LSRCFHCATHD,2109071, 765211, 44376128
14) LSRCFHCATHD,2109071, 765211, 44376127
15) LSRCFHCATHD,2109071, 765211, 44376129
16) LSRCFHCATHD,2109071, 765211, 44376130
17) LSRCUSTCATHG,2109201, 754211, 44373704
18) LSRCFHCATHD,2109271, 740211, 15142078
19) MMCC14D,2104143, 898211, 64033893
20) IHCC03R,2107061, 819211, 44183402
21) HGCL69G,2107202, 803211, 15053840
22) UIRD89AE,2107293, 793211, 44181939
23) AMCL05M,2108131, 777211, 64230198
24) HGCL69G,2108313, 761211, 15062583
25) SHCA31I,2105142, 866211, 44111393-005
26) CXDP36N,2105241, 858211, 14854252-004
27) SHCA31I,2105261, 855211, 44131698-005
28) BLCL72K,2106141, 835211, 14994491-004
29) SACL75AK,2106212, 828211, 64071585-006
30) MECL20V,2107292, 805211, 44235192-005
31) SACL75AK,2107302, 789211, 64109974-006
32) SLBT02H,2108051, 784211, 44234510-005
33) AHCC27X,2109092, 748211, 64209383-006
34) BHCA49I,2107161, 817211, 44228705-005
35) BHCA49I,2107161, 817211, 44228708-005
36) SHCC17E,2107292, 793211, 44219151-005
37) SHIR38E,2108192, 721211, 14977781-004
38) BHCA49I,2108241, 768211, 44215236-005
39) BHCA49I,2108241, 768211, 44335430-005
40) BHCA49I,2108241, 768211, 44336206-005
41) TMCC25I,2108312, 764211, 63999207-006
42) TMCC25I,2108312, 764211, 63999208-006
43) TMCC25I,2108312, 764211, 63999206-006
44) TMCC25I,2108312, 764211, 63999205-006
45) TMCC25I,2108312, 764211, 63999204-006
46) SHDW24G,2109071, 754211, 44344585-005
47) SHDW24G,2109071, 754211, 44344586-005
48) SHDW24G,2109071, 754211, 44344587-005
49) SHDW24G,2109071, 754211, 44344588-005
50) SHDW24G,2109071, 754211, 44344589-005
51) MPCA63J,2104141, 917211, 64008477-006
52) SJCH22F,2106141, 840211, 64133201-006
53) MCCP02G,2106151, 838211, 64131832-006
54) WHAC86C,2106161, 835211, 64132953-006
55) MCCP02G,2107231, 798211, 64141288-006
56) SNCP60F,2108041, 788211, 64141247-006
57) MCCP02G,2109131, 753211, 64134924-006
58) MCCP02G,2109131, 753211, 64135604-006
59) FBHC45H,2105131, 870211, 14576957-004
60) AGLH66F,2106241, 834211, 44167857-005
61) AGLH66G,2108251, 765211, 44288730-005
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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
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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 |
61 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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