| | Class 2 Device Recall Various convenience packs |  |
| Date Initiated by Firm | June 16, 2022 |
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| Create Date | September 08, 2022 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1699-2022 |
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| Recall Event ID |
90574 |
| Product Classification |
Orthopedic tray - Product Code OJH
|
| Product | Various convenience packs |
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| Code Information |
Tray Number, Sterilization Lot, Lot Number, Bag Serial Number
1) LSRHUMTOTPKC, 2104192, 894211, 14881385
2) LSRLMHANDA, 2104221, 901211, 64119577
3) LSRHUMTOTPKC, 2104192, 894211, 14881385
4) LSRTOTJOINTM, 2104301, 888211, 63993926
5) LSRTOTJOINTM, 2104301, 888211, 63993926
6) LSRLMHANDA, 2105101, 883211, 63991195
7) LSRORTHOMINH, 2107221, 818211, 64119458
8) LSRTOTJOINTM, 2107171, 809211, 64116601
9) LSRTOTJOINTM, 2107171, 809211, 64116600
10) LSRSMANTHF, 2107171, 810211, 64116603
11) LSRARTHROSE, 2108251, 785211, 44139253
12) LSRORTHOMINH, 2108251, 778211, 64119583
13) LSRORTHOMINH, 2108251, 778211, 64119582
14) LSRORTHOMINH, 2109162, 754211, 64318299
15) LSRORTHOMINH, 2109162, 754211, 64318298
16) LSRORTHOMINH, 2109162, 754211, 64318717
17) LSRTOTJOINTM, 2109231, 747211, 64319310
18) LSRORTHOMINH, 2110011, 735211, 64318801
19) MKMA57I, 2104061, 909211, 64024798
20) UICA66AG, 2104122, 902211, 64034679
21) FDPD04AB, 2104143, 901211, 64034128
22) UIEB90G, 2104162, 895211, 14779410
23) UIOS80W, 2106291, 825211, 64170682
24) PCTS17E, 2107192, 803211, 64164240
25) AMTK03AF, 2108162, 776211, 64231145
26) UIKN28AN, 2108202, 771211, 64230570
27) UIHN18AP, 2108193, 771211, 64231011
28) UIHN18AP, 2108193, 771211, 64230951
29) TNTK20U, 2108262, 763211, 64237810
30) LMHN50S, 2109023, 758211, 64234603
31) SCAR03U, 2104151, 895211, 44124761-005
32) BHTK51, 2104191, 891211, 63978560-006
33) SETK12E, 2104261, 887211, 63985987-006
34) SETK12E, 2104261, 887211, 63985736-006
35) FHOM26X, 2104301, 882211, 44123694-005
36) UIOS80V, 2105051, 880211, 63984525-006
37) LOAP10B, 2105102, 870211, 63958629-006
38) SLTH18F, 2105102, 870211, 63958630-006
39) FTHD18I, 2105192, 866211, 63956743-006
40) FAUE10AC, 2105241, 858211, 44133505-005
41) SSTK16F, 2105262, 854211, 63955145-006
42) SHKN28C, 2105271, 854211, 64074676-006
43) FLOR01I, 2106072, 842211, 64074728-006
44) CXOS01T, 2106101, 841211, 44128814-005
45) FHSH28AC, 2107022, 818211, 64112048-006
46) SFAR59E, 2107093, 810211, 44244601-005
47) SLUE07D, 2107101, 809211, 64099712-006
48) AHEX25K, 2107162, 803211, 44244629-005
49) AHEX25K, 2107162, 803211, 44244631-005
50) AHEX25K, 2107162, 803211, 44244630-005
51) AHEX25K, 2107162, 803211, 44244628-005
52) FTHD18I, 2107191, 800211, 64098800-006
53) FTHD18I, 2107191, 800211, 64098798-006
54) FTHD18I, 2107191, 800211, 64098797-006
55) FTHD18I, 2107191, 800211, 64098799-006
56) FHTK32AD, 2107241, 795211, 64097109-006
57) SAOR89Z, 2107292, 791211, 64109976-006
58) FHHP63S, 2108022, 789211, 15007401-004
59) SETK12E, 2108052, 785211, 64107496-006
60) CXHA75H, 2108062, 782211, 15003851-005
61) FAUE10AC, 2108141, 775211, 44239520-005
62) SFAR59E, 2108172, 771211, 44239251-005
63) COPO63, 2108201, 769211, 44316565-005
64) BHLE58G, 2108252, 763211, 44315273-005
65) SFTK53H, 2108313, 757211, 64204506-006
66) CBTJ34H, 2109101, 747211, 64209800-006
67) PREX34U, 2109142, 749211, 64208358-006
68) SAAR74T, 2109162, 741211, 44318763-005
69) MESA11O, 2109211, 741211, 64220362-006
70) FHOM26X, 2109222, 737211, 44316980-005
71) ATTO11J, 2109232, 735211, 64220363-006
72) BHEX32D, 2104291, 894211, 64068954-006
73) BHEX32D, 2104291, 894211, 64068953-006
74) DSEX64D, 2105052, 880211, 14954450-004
75) BHHS55C, 2105191, 883211, 64063386-006
76) BHHD71E, 2105212, 863211, 14974551-004
77) BHAR12C, 2105252, 859211, 64063803-006
78) BHAR12C, 2105252, 859211, 64063802-006
79) BHEX32D, 2106091, 847211, 64045606-006
80) BHEX32D, 2106081, 847211, 64046915-006
81) BHHS55C, 2106082, 848211, 64045553-006
82) UMOR21B, 2106162, 838211, 44210738-005
83) NCTH24J, 2106303, 821211, 64090017-006
84) BHAR12C, 2107091, 820211, 64089228-006
85) BHHS55C, 2107091, 826211, 64088772-006
86) BHHS55C, 2107091, 826211, 64088773-006
87) BHHD26F, 2107221, 803211, 44227720-005
88) BHHD26F, 2107221, 803211, 44227722-005
89) BHHD26F, 2107221, 803211, 44227721-005
90) BHHS55C, 2107271, 798211, 64096266-006
91) BHEX32D, 2108092, 784211, 64094371-006
92) BHEX32D, 2108092, 784211, 64094370-006
93) BHEX32D, 2108092, 784211, 64094201-006
94) BHEX32D, 2108092, 784211, 64094200-006
95) BHEX32D, 2108092, 784211, 64094199-006
96) BHEX32D, 2108092, 784211, 64093655-006
97) BHAR12C, 2108112, 779211, 64093730-006
98) BHAR12C, 2108112, 779211, 64093746-006
99) BHAR12C, 2108112, 779211, 64093745-006
100) BHHS55C, 2108131, 777211, 64093727-006
101) NCTK31J, 2109083, 756211, 63998080-006
102) BHEX32D, 2109141, 748211, 64310593-006
103) BHEX32D, 2109141, 748211, 64310594-006
104) BHEX32D, 2109141, 748211, 64310759-006
105) BHEX32D, 2109141, 748211, 64310592-006
106) BHHS55C, 2109212, 747211, 64310388-006
107) DRSP17A, 2104141, 903211, 63861576-006
108) DRSP17A, 2104141, 903211, 63861575-006
109) SATO27E, 2104091, 904211, 64009103-006
110) WHTK06B, 2106301, 826211, 64130783-006
111) MPKK10B, 2107061, 818211, 64128810-006
112) UTSA18P, 2104271, 888211, 44175244-005
113) UTSA18P, 2104271, 888211, 44175243-005
114) UTSA18P, 2104271, 888211, 44175238-005
115) UTSA18P, 2104271, 888211, 44175235-005
116) GREX13I, 2105041, 877211, 14912665-004
117) AHSC20B, 2107061, 821211, 44167441-005
118) AHKA41C, 2109221, 740211, 64285900-006
|
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. |
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FDA Determined
Cause 2 | Process change control |
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| 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. |
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| Quantity in Commerce | 118 units |
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| 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 |
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| 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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