Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93656

18 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 29, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
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

18 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 18

Custom procedural convenience kits and trays, anesthesia, labeled as: a) HEART ANESTHESIA BUNDLE NS, Kit Number LMHA01V; b) OR/Anesthesia Central Line Insertion Kit, Kit Number UIAN43L

Z-0816-2024
Recall number
Z-0816-2024
Initiated
November 29, 2023
Classification
Class II
Status
Ongoing
Quantity
182 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the piggybacked components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.

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

During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the piggybacked components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.

Code information

a) LMHA01V: No UDI/DI, Lot Numbers: 702221, exp. 10/25/223; 654221, exp. 12/12/2023; 954231, exp. 2/15/2024; 903231, exp. 4/7/2024; b) UIAN43L: No UDI/DI, Lot Numbers: 654221, exp. 12/12/2023; 991231, exp. 1/9/2024

Distribution pattern

US Nationwide distribution.

device · product 2 of 18

Custom procedural convenience kits and trays, cardiac, labeled as: a) HEART CATHETERIZATION TRAY, kit number JRHC45G; b) TAVR PACK, kit number LLTV10; c) CATH PED LF SJH, kit number SJCA21F; d) CATH HEART ADL LF SJH, kit number SJCH22F; e) INT RAD PORTS-LF - 206060, kit number UDIR58AL

Z-0817-2024
Recall number
Z-0817-2024
Initiated
November 29, 2023
Classification
Class II
Status
Ongoing
Quantity
4394 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the piggybacked components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.

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

During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the piggybacked components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.

Code information

a) JRHC45G, UDI/DI 00191072164240, Lot Numbers: 912231, exp. 3/29/2024; 920231, exp. 3/21/2024; 952231, exp. 2/17/2024; 963231, exp. 2/6/2024; 976231, exp. 6/2/2023; 654221, exp. 12/12/2023; 714221, exp. 10/13/2023; 717221, exp. 6/7/2023; 766221, exp. 8/22/2023; 814221, exp. 7/5/2023; b) LLTV10, UDI/DI 00191072183255, Lot Numbers: 644221, exp. 12/22/2023; 973231, exp. 1/27/2024; 952231, exp. 2/17/2024; 924231, exp. 3/17/2024; c) SJCA21F, UDI/DI None, Lot Numbers: 666221, exp. 11/30/2023; 701221, exp. 10/26/2023; 747221, exp. 9/10/2023; 779221, exp. 8/9/2023; 807221, exp. 7/12/2023; 846221, exp. 6/3/2023; 919231, exp. 3/22/2024; 954231, exp. 2/15/2024; 988231, exp. 1/12/2024; d) SJCH22F, UDI/DI None, Lot Numbers: 670221, exp. 11/26/2023; 708221, exp. 10/19/2023; 747221, exp. 9/10/2023; 795221, exp. 7/24/2023; 834221, exp. 6/15/2023; 873221, exp. 5/7/2023; 937231, exp. 3/4/2024; 991231, exp. 1/9/2024; e) UDIR58AL, UDI/DI None, Lot Numbers: 682221, exp. 11/14/2023; 638221, exp. 7/31/2023; 963231, exp. 2/6/2024; 925231, exp. 3/16/2024; 883231, exp. 10/30/2023

Distribution pattern

US Nationwide distribution.

device · product 3 of 18

Procedural convenience kits and trays, cardiac, labeled as: a) EP LAB BI V IMPLANT PACK, kit number AGBI64J; b) LAB DEVICE IMPLANT, kit number AGDI40J; c) LAB DEVICE IMPLANT, kit number AGDI40K; d) MINOR VASCULAR, kit number AGMV26O; e) OPEN HEART ACCESSORY, kit number AGOH98Q; f) OPEN HEART ACCESSORY, kit number AGOH98R; g) OPEN HEART ACCESSORY, kit number AGOH98S; h) PERIPHERAL VASCULAR, kit number AGPV28O; i) PERIPHERAL VASCULAR, kit number AGPV28P; j) MINOR VASCULAR, kit number AHMV26J; k) MINOR VASCULAR, kit number AHMV26K; l) HEART PACK - 205947, kit number ANCV78AX; m) HEART PACK - 205947 , kit number ANCV78AX1; n) HEART PACK - 205947 Post Open-Heart, kit number ANHK74N; o) OPEN HEART EAST PACK, kit number BHOH43; p) 74OFF PUMP CABG PACK, kit number BHOP48; q) PACEMAKER PACK, kit number BHPM60; r) FORBES EP LAB DEVICE IMPLANT PK, kit number FBDI42K; s) T AND A PACK AGH ASC, kit number FBDI42L; t) T AND A PACK AGH ASC, kit number FBDI42M; u) THORACOSCOPY PACK, kit number FBTO60G; v) OPEN HEART ACCESSORY PACK, kit number JROH00O; w) OPEN HEART ACCESSORY PACK, kit number JROH98O; x) ADULT OPEN HEART PACK, kit number LLOH52; y) ADULT OPEN HEART PACK, kit number LLOP25; z) PACEMAKER PACK, kit number LLPP14; aa) HEART PACK, kit number LMCB06AD; bb) CARDIAC HEART BUNDLE NS, kit number LMCH99O; cc) OPEN HEAART PACK, kit number LMOH50AD; dd) OPEN HEAART PACK, kit number LMOH50AD-01; ee) OPEN HEAART PACK, kit number LMOH50AD-02; ff) OPEN HEAART PACK, kit number LMOH50AE; gg) CV PACK, kit number MMCV98V; hh) CV PACK, kit number MMCV98V-03; ii) CV PACK, kit number MMCV98V-04; jj) KIT OPEN HEART ADULT, kit number MMOH64J; kk) PACEMAKER PACK, kit number MMPM27E; ll) KIT, THORACOTOMY UNIVERSAL, kit number MMTR12F; mm) ANT CERV FUSION PACK, kit number NCAC96; nn) OPEN HEART- ACCESSOR, kit number NCOH11; oo) VASCULAR SAH, kit number SAVA91G; pp) VASCULAR SAH, kit number SAVA91H; qq) VASCULAR SAH, kit number SAVA91I; rr) VASCULAR SAH, kit number SAVA91J; ss) OPEN HEART BRINGBACK SJH, kit number SJOH17I; tt) OPEN HEART CV SJH, kit number SJOH28L; uu) PEDIATRIC HEART SJH, kit number SJPH34K; vv) VASC OPEN CVOR SJH, kit number SJVO56A; ww) VASC OPEN CVOR SJH, kit number SJVO56B; xx) MAJOR CV TRAY, kit number SVMJ20L; yy) MAJOR CV TRAY, kit number SVMJ20M; zz) MINOR CV TRAY¿, kit number SVMN60J; aaa) OPEN HEART COMPONENT PACK, kit number SVOH38Q; bbb) CV B PACK, kit number TNCB10AK; ccc) CARDIOVASCULAR SUPPLY (PS 907285), kit number UICD62AM

Z-0818-2024
Recall number
Z-0818-2024
Initiated
November 29, 2023
Classification
Class II
Status
Ongoing
Quantity
12291 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the piggybacked components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.

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

During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the piggybacked components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.

Code information

a) AGBI64J, UDI/DI 0019107247578, Lot numbers: 956231, exp. 2/13/2024; 674221, exp. 11/22/2023; 699221, exp. 10/28/2023; 727221, exp. 9/30/2023; 731221, exp. 9/26/2023; 769221, exp. 8/19/2023; 876221, exp. 5/4/2023; b) AGDI40J, UDI/DI 00191072154668, Lot numbers: 956231, exp. 7/31/2023; 647221, exp. 7/31/2023; 708221, exp. 7/31/2023; 750221, exp. 7/31/2023; c) AGDI40K, UDI/DI 00191072188168, Lot numbers: 910231, exp. 3/31/2024; 904231, exp. 4/6/2024; d) AGMV26O, UDI/DI 00191072179777, Lot numbers: 900231, exp. 2/23/2024; 912231, exp. 2/23/2024; 949231, exp. 2/20/2023; 982231, exp. 1/18/2024; 666221, exp. 11/30/2023; 713221, exp. 10/14/2023; 763221, exp. 8/25/2023; 822221, exp. 6/27/2023; e) AGOH98Q, UDI/DI 00191072159419, Lot numbers: 846221, exp. 6/3/2023; f) AGOH98R, UDI/DI 00191072169754, Lot numbers: 742221, exp. 9/15/2023; 772221, exp. 8/16/2023; 794221, exp. 7/25/2023; g) AGOH98S, UDI/DI 00191072179784, Lot numbers: 921231, exp. 7/31/2023; 636221, exp. 10/10/2023; 685221, exp. 11/11/2023; 707221, exp. 7/31/2023; 729221, exp. 7/31/2023; h) AGPV28O, UDI/D I00191072137210, Lot numbers: 847221, exp. 6/2/2023; i) AGPV28P, UDI/DI 00191072179791, Lot numbers: 771221, exp. 8/17/2023; 961231, exp. 2/8/2024; 696221, exp. 10/31/2023; j) AHMV26J, UDI/DI 00191072137586, Lot numbers: 735221, exp. 9/22/2023; 790221, exp. 7/29/2023; 839221, exp. 6/10/2023; k) AHMV26K, UDI/DI 00191072179807, Lot numbers: 896231, exp. 4/14/2024; 977231, exp. 1/23/2024; 953231, exp. 2/16/2024; 969231, exp. 1/31/2024; 686221, exp. 11/10/2023; 721221, exp. 10/6/2023; l) ANCV78AX, UDI/DI 00191072182692, Lot numbers: 706221, exp. 10/21/2023; m) ANCV78AX1, UDI/DI 00191072182692, Lot numbers: 647221, exp. 12/19/2023; n) ANHK74N, UDI/DI 00191072191472, Lot numbers: 706221, exp. 10/21/2023; o) BHOH43, UDI/DI 00191072160690, Lot numbers: 960231, exp. 2/9/2023; 668221, exp. 11/28/2023; 734221, exp. 9/23/2023; 773221, exp. 8/15/2023; 828221, exp. 6/21/2023; 876221, exp. 5/4/2023; 902221, exp. 4/8/2023; p) BHOP48, UDI/DI 00191072164131, Lot numbers: 921231, exp. 3/20/2024; 948231, exp. 2/21/2024; 984231, exp. 1/16/2024; 783221, exp. 8/5/2023; 688221, exp. 1/8/2023; 736221, exp. 9/12/2023; 833221, exp. 6/16/2023; 867221, exp. 5/13/2023; 903221, exp. 4/7/2023; q) BHPM60, UDI/DI 00191072160799, Lot numbers: 928231, exp. 3/13/2024; 968231, exp. 2/1/2024; 651221, exp. 12/15/2023; 702221, exp. 10/25/2023; 762221, exp. 8/26/2023; 836221, exp. 6/13/2023; 883221, exp. 4/27/2023; r) FBDI42K, UDI/DI 00191072169761, Lot numbers: 976231, exp. 7/31/2023; 644221, exp. 7/31/2023; 678221, exp. 7/31/2023; 716221, exp. 7/31/2023; 743221, exp. 7/31/2023; 758221, exp. 7/31/2023; 828221, exp. 6/21/2023; 846221, exp. 6/3/2023; s) FBDI42L, UDI/DI 00191072189905, Lot numbers: 920231, exp. 7/31/2023; 942231, exp. 7/31/2023; t) FBDI42M, UDI/DI 00191072192066, Lot numbers: 899231, exp. 4/11/2024; u) FBTO60G, UDI/DI 00191072164219, Lot numbers: 654221, exp. 12/12/2023; 689221, exp. 11/7/2023; v) JROH00O, UDI/DI 00191072179814, Lot numbers: 906231, exp. 4/4/2024; 932231, exp. 3/9/2024; 935231, exp. 8/21/2023; 968231, exp. 2/1/2024; 988231, exp. 12/9/2023; w) JROH98O, UDI/DI 00191072179821, Lot numbers: 900231, exp. 4/10/2024; 657221, exp. 11/18/2023; 686221, exp. 10/14/2023; 713221, exp. 9/14/2023; x) LLOH52, UDI/DI 00191072169785, Lot numbers: 729221, exp. 9/28/2023; 722221, exp. 10/5/2023; 668221, exp. 11/28/2023; 980231, exp. 1/20/2024; 903231, exp. 4/7/2024; y) LLOP25, UDI/DI 00191072167347, Lot numbers: 766221, exp. 8/22/2023; 729221, exp. 9/28/2023; z) LLPP14, UDI/DI 00191072167354, Lot numbers: 741221, exp. 9/16/2023; 695221, exp. 11/1/2023; 639221, exp. 12/27/2023; 940231, exp. 3/1/2024; aa) LMCB06AD, UDI/DI none, Lot numbers: 721221, exp. 10/6/2023; 675221, exp. 11/21/2023; 927231, exp. 3/14/2024; 890231, exp. 4/20/2024; bb) LMCH99O, UDI/DI none, Lot numbers: 762221, exp. 8/26/2023; 715221, exp. 10/12/2023; 674221, exp. 11/22/2023; 872231, exp. 5/8/2024; cc) LMOH50AD, UDI/DI 00191072165534, Lot numbers: 847221, exp. 6/2/2023; 833221, exp. 6/16/2023; 807221, exp. 7/12/2023; 751221, exp. 8/27/2023; dd) LMOH50AD-01, UDI/DI 0019107216553 , Lot numbers: 878221, exp. 5/2/2023; 765221, exp. 8/23/2023; ee) LMOH50AD-02, UDI/DI 00191072165534, Lot numbers: 731221, exp. 9/26/2023; 682221, exp. 11/14/2023; ff) LMOH50AE, UDI/DI 00191072184443, Lot numbers: 973231, exp. 1/27/2024; gg) MMCV98V, UDI/DI 00191072155481, Lot numbers: 867221, exp. 5/13/2023; 828221, exp. 6/21/2023; 949231, exp. 2/20/2024; hh) MMCV98V-03, UDI/DI 00191072155481, Lot numbers: 783221, exp. 8/5/2023; ii) MMCV98V-04, UDI/DI 00191072155481, Lot numbers: 681221, exp. 11/15/2023; jj) MMOH64J, UDI/DI none, Lot numbers: 933231, exp. 3/8/2024; 871231, exp. 5/9/2024; kk) MMPM27E, UDI/DI none, Lot numbers: 935231, exp. 3/6/2024; ll) MMTR12F, UDI/DI none, Lot numbers: 889231, exp. 4/21/2024; mm) NCAC96, UDI/DI 00191072016829, Lot numbers: 963231, exp. 8/18/2023; 996231, exp. 6/2/2023; 715221, exp. 6/2/2023; 811221, exp. 6/2/2023; 863221, exp. 5/17/2023; nn) NCOH11, UDI/DI 00191072160867, Lot numbers: 956231, exp. 2/13/2024; 674221, exp. 11/22/2023; 751221, exp. 4/6/2023; 827221, exp. 6/22/2023; 864221, exp. 5/16/2023; oo) SAVA91G, UDI/DI none, Lot numbers: 824221, exp. 6/25/2023; 870221, exp. 5/10/2023; pp) SAVA91H, UDI/DI none, Lot numbers: 790221, exp. 7/29/2023; qq) SAVA91I, UDI/DI none, Lot numbers: 702221, exp. 10/25/2023; 742221, exp. 9/15/2023; rr) SAVA91J, UDI/DI none, Lot numbers: 667221, exp. 10/31/2023; 946231, exp. 2/23/2024; 989231, exp. 1/11/2024; ss) SJOH17I, UDI/DI none, Lot numbers: 696221, exp. 10/31/2023; 747221, exp. 9/10/2023; 778221, exp. 8/10/2023; 817221, exp. 7/2/2023; 863221, exp. 5/17/2023; 988231, exp. 1/12/2024; tt) SJOH28L, UDI/DI none, Lot numbers: 650221, exp. 12/16/2023; 702221, exp. 10/25/2023; 744221, exp. 9/13/2023; 792221, exp. 7/27/2023; 838221, exp. 6/11/2023; 888221, exp. 4/22/2023; 961231, exp. 2/8/2024; 918231, exp. 3/23/2024; uu) SJPH34K, UDI/DI none, Lot numbers: 678221, exp. 11/18/2023; 750221, exp. 9/7/2023; 818221, exp. 7/1/2023; 975231, exp. 1/25/2024; vv) SJVO56A, UDI/DI none, Lot numbers: 763221, exp. 8/25/2023; ww) SJVO56B, UDI/DI none, Lot numbers: 636221, exp. 12/30/2023; 661221, exp. 12/5/2023; 686221, exp. 11/10/2023; 707221, exp. 10/20/2023; 911231, exp. 3/30/2024; 940231, exp. 3/1/2024; 974231, exp. 1/26/2024; xx) SVMJ20L, UDI/DI 00191072142405, Lot numbers: 737221, exp. 9/20/2023; 807221, exp. 7/12/2023; 863221, exp. 5/17/2023; yy) SVMJ20M, UDI/DI 00191072179838, Lot numbers: 903231, exp. 4/7/2024; 955231, exp. 2/14/2024; 681221, exp. 11/15/2023; zz) SVMN60J, UDI/DI 00191072142412, Lot numbers: 654221, exp. 12/12/2023; 734221, exp. 9/23/2023; 784221, exp. 8/4/2023; 836221, exp. 6/13/2023; aaa) SVOH38Q, UDI/DI 00191072156488, Lot numbers: 913231, exp. 3/28/2024; 891231, exp. 4/19/2024; 953231, exp. 2/16/2024; 961231, exp. 2/8/2024; 637221, exp. 12/29/2023; 651221, exp. 12/15/2023; 710221, exp. 10/17/2023; 729221, exp. 9/28/2023; 784221, exp. 7/31/2023; bbb) TNCB10AK, UDI/DI 00191072184948, Lot numbers: 995231, exp. 1/5/2024; ccc) UICD62AM, UDI/DI none, Lot numbers: 959231, exp. 2/10/2024; 879231, exp. 5/1/2024

Distribution pattern

US Nationwide distribution.

device · product 4 of 18

Custom procedural convenience kits and trays, cardiac, labeled as: a) CENTRAL LINE INSERTION PACK, kit number LLCE52; b) Adult Central Line Insertion Supply Kit, kit number UICL44N; c) Pediatric Central Line Insertion, kit number UIPL77K

Z-0819-2024
Recall number
Z-0819-2024
Initiated
November 29, 2023
Classification
Class II
Status
Ongoing
Quantity
290 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the piggybacked components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.

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

During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the piggybacked components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.

Code information

a) LLCE52, UDI/DI 00191072030832, Lot Numbers: 912231, exp. 11/30/2023; b) UICL44N, UDI/DI 00191072142696, Lot Numbers: 991231, exp. 1/9/2024; 891231, exp. 1/30/2024 c) UIPL77K, UDI/DI 00191072142801, Lot Numbers: 748221, exp. 9/9/2023; 650221, exp. 12/16/2023; 919231, exp. 3/22/2024

Distribution pattern

US Nationwide distribution.

device · product 5 of 18

Custom procedural convenience kits and trays, ear, nose & throat, labeled as: a) T AND A PACK AGH ASC, kit number AGTA48J; b) OPSC EAR PACK, kit number LLEO66; c) T AND A PACK, kit number MMTA41F

Z-0820-2024
Recall number
Z-0820-2024
Initiated
November 29, 2023
Classification
Class II
Status
Ongoing
Quantity
804 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the piggybacked components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.

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

During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the piggybacked components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.

Code information

a) AGTA48J, UDI/DI 00191072142870, lot numbers: 890231, exp. 45402; 920231, exp. 45372; 941231, exp. 45350; 976231, exp. 45315; 645221, exp. 45281; 659221, exp. 45267; 686221, exp. 45240; 755221, exp. 45171; 836221, exp. 45090; b) LLEO66, UDI/DI 00191072165541, lot numbers: 813221, exp. 7/6/2023; 763221, exp. 8/25/2023; 696221, exp. 10/31/2023; 984231, exp. 1/16/2024; 905231, exp. 4/5/2024; c) MMTA41F, UDI/DI none, lot numbers: 899231, exp. 4/11/2024

Distribution pattern

US Nationwide distribution.

device · product 6 of 18

Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: AHN BIOPSY STERILE, kit number AHBP12A

Z-0821-2024
Recall number
Z-0821-2024
Initiated
November 29, 2023
Classification
Class II
Status
Ongoing
Quantity
95 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the piggybacked components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.

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

During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the piggybacked components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.

Code information

AHBP12A, UDI/DI 00191072188229, Lot Numbers: 963231, exp. 1/21/2024; 940231, exp. 1/21/2024; 996231, exp. 2/28/2023

Distribution pattern

US Nationwide distribution.

device · product 7 of 18

Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: a) LAP KIDNEY MODULE, kit number AGKD50L; b) ROBOTIC PROSTATE PACK - 264852, kit number ANPR34S; c) LAP CHOLE - 213388, kit number BFLC02AD; d) GENERAL LAPAROSCOPY PACK, kit number GUGE09I; e) LAP CHOLE PACK, kit number HNLC80I; f) Lap Chole Ovarian Appy, kit number JSLC06I; g) LAP CHOLE, ST LUKES, kit number LMLP08Z; h) ROBOTIC PACK - 242561, kit number MHRB88AJ; i) KIT, GENERAL LAPAROSCOPY, kit number MMLP40F; j) KIT, MAJOR LAPAROTOMY, kit number MMML26F; k) LAP CHOLE - LAP HERNIA PACK - 282807, kit number OWLC07K; l) GENERAL LAPAROSCOPY SAH, kit number SAGL57H; m) ROBOTIC PACK SAH, kit number SARB30K; n) ROBOTIC PACK SAH, kit number SARB30L; o) ROBOTIC PACK SAH, kit number SARB30M; p) LAP CHOLE PACK, kit number SMLC53; q) ROBOTICS PACK, kit number SNRP85D; r) ROBOTIC PACK, kit number SSRO22C; s) ROBOTIC PACK, kit number SSRO22D; t) TPK DAVINCI PROSTATE SYSTEM, kit number TPDV16; u) ASC LAP CHOLE PACK (PS 42279), kit number UICH53Y; v) GENERAL LAPAROSCOPIC PACK, kit number WVGL60E

Z-0822-2024
Recall number
Z-0822-2024
Initiated
November 29, 2023
Classification
Class II
Status
Ongoing
Quantity
3196 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the piggybacked components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.

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

During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the piggybacked components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.

Code information

a) AGKD50L, UDI/DI 00191072141156, Lot Numbers: 905231, exp. 4/5/2024; 638221, exp. 12/28/2023; 689221, exp. 5/21/2023; b) ANPR34S, UDI/DI 00191072171351, Lot Numbers: 721221, exp. 10/6/2023; 879231, exp. 5/1/2024; 896231, exp. 4/14/2024; 927231, exp. 3/14/2024; 956231, exp. 2/13/2024; 645221, exp. 12/21/2023; c) BFLC02AD, UDI/DI 00191072169075, Lot Numbers: 654221, exp. 12/12/2023; 647221, exp. 12/19/2023; 987231, exp. 1/13/2024; UDI/DI 00191072188830, Lot Numbers: 946231, exp. 2/23/2024; 896231, exp. 4/14/2024; d) GUGE09I, UDI/DI none, Lot Numbers: 768221, exp. 8/20/2023; e) HNLC80I, UDI/DI 00191072146267, Lot Numbers: 797221, exp. 7/22/2023; 679221, exp. 11/17/2023; 995231, exp. 1/25/2024; 911231, exp. 3/30/2024; f) JSLC06I, UDI/DI 00191072126061, Lot Numbers: 839221, exp. 6/10/2023; 766221, exp. 8/22/2023; g) LMLP08Z, UDI/DI none, Lot Numbers: 661221, exp. 12/5/2023; 987231, exp. 1/13/2024; 942231, exp. 2/27/2024; 893231, exp. 4/17/2024; h) MHRB88AJ, UDI/DI none, Lot Numbers: 735221, exp. 9/22/2023; 710221, exp. 10/17/2023; 997231, exp. 1/3/2024; 959231, exp. 2/10/2024; 904231, exp. 4/6/2024; i) MMLP40F, UDI/DI none, Lot Numbers: 933231, exp. 3/8/2024; 879231, exp. 5/1/2024; j) MMML26F, UDI/DI none, Lot Numbers: 989231, exp. 1/11/2024; 896231, exp. 4/14/2024; k) OWLC07K, UDI/DI none, Lot Numbers: 682221, exp. 11/14/2023; 646221, exp. 12/20/2023; 982231, exp. 1/18/2024; 928231, exp. 3/13/2024; l) SAGL57H, UDI/DI none, Lot Numbers: 687221, exp. 11/9/2023; 790221, exp. 7/29/2023; m) SARB30K, UDI/DI none, Lot Numbers: 845221, exp. 6/4/2023; 888221, exp. 4/22/2023; n) SARB30L, UDI/DI none, Lot Numbers: 752221, exp. 9/5/2023; o) SARB30M, UDI/DI none, Lot Numbers: 658221, exp. 12/8/2023; 700221, exp. 10/27/2023; 792221, exp. 7/27/2023; 949231, exp. 2/20/2024; 983231, exp. 1/17/2024; p) SMLC53, UDI/DI 00191072188465, Lot Numbers: 969231, exp. 1/31/2024; q) SNRP85D, UDI/DI none, Lot Numbers: 666221, exp. 11/30/2023; 720221, exp. 10/7/2023; 793221, exp. 7/26/2023; 853221, exp. 5/27/2023; 965231, exp. 2/4/2024; r) SSRO22C, UDI/DI none, Lot Numbers: 891221, exp. 04/19/2023; s) SSRO22D, UDI/DI none, Lot Numbers: 660221, exp. 5/31/2023; 698221, exp. 10/29/2023; 756221, exp. 9/1/2023; 804221, exp. 7/15/2023; 840221, exp. 6/9/2023; 933231, exp. 8/31/2023; 987231, exp. 1/13/2024; t) TPDV16, UDI/DI 00191072128904, Lot Numbers: 856221, exp. 5/24/2023; 744221, exp. 9/13/2023; 675221, exp. 11/21/2023; 932231, exp. 3/9/2024; u) UICH53Y, UDI/DI none, Lot Numbers: 897231, exp. 4/13/2024; 882231, exp. 4/28/2024; v) WVGL60E, UDI/DI 00191072144034, Lot Numbers: 766221, exp. 8/22/2023; 694221, exp. 11/2/2023; 952231, exp. 2/17/2024;

Distribution pattern

US Nationwide distribution.

device · product 8 of 18

Custom procedural convenience kits and trays, urological, labeled as: a) UROLOGY DAVINCI PACK, kit number HGUR87G; b) CYSTO PACK, kit number LVCY20; c) URO ROBOTIC PACK, kit number LVUR44;

Z-0823-2024
Recall number
Z-0823-2024
Initiated
November 29, 2023
Classification
Class II
Status
Ongoing
Quantity
1031 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the piggybacked components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.

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

During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the piggybacked components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.

Code information

a) HGUR87G, UDI/DI none, Lot Numbers: 751221, exp. 9/6/2023; 651221, exp. 12/15/2023; 973231, exp. 1/27/2024; 939231, exp. 3/2/2024; b) LVCY20, UDI/DI 00191072117991, Lot Numbers: 769221, exp. 8/19/2024; 727221, exp. 9/30/2024; 701221, exp. 10/26/2023; 643221, exp. 12/23/2023; 912231, exp. 3/29/2024; c) LVUR44, UDI/DI 00191072136688, Lot Numbers: 846221, exp. 6/3/2023; 938231, exp. 3/3/2024

Distribution pattern

US Nationwide distribution.

device · product 9 of 18

Custom procedural convenience kits and trays, general & plastic surgery, labeled as: a) Breast Plastics Pack, kit number BBPL20D; b) MINOR PLASTIC, kit number WPMP16H

Z-0824-2024
Recall number
Z-0824-2024
Initiated
November 29, 2023
Classification
Class II
Status
Ongoing
Quantity
112 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the piggybacked components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.

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

During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the piggybacked components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.

Code information

a) BBPL20D, Lot Codes: 862221, exp. 5/18/2023; 688221, exp. 5/31/2023; 756221, exp. 9/1/2023; 782221, exp. 8/6/2023; b) WPMP16H,Lot Codes: 904231, exp. 4/6/2024; 966231, exp. 2/3/2024; 650221, exp. 12/16/2023; 708221, exp. 10/19/2023; 805221, exp. 7/14/2023; 888221, exp. 4/22/2023; 867221, exp. 5/13/2023

Distribution pattern

US Nationwide distribution.

device · product 10 of 18

Custom procedural convenience kits and trays, general & plastic surgery, labeled as: a) BRACHY THERAPY PROCEDURE PAC, kit number AGBR90E; b) BRACHY THERAPY PROCEDURE PAC, kit number AGBR90E; c) MINI MINOR AGH ASC PACK, kit number AGMM60M; d) OUTPATIENT PORT ACCESS KIT 307907, kit number AHPO55J; e) General Pack, kit number BBGP31C; f) FRACTURE TABLE PACK, kit number FDFT75N; g) Arthroscopy Pack, kit number HCAR04K; h) BARIATRIC PACK, kit number HGBA92F; i) LAPAROTOMY PACK, kit number HNLP12J; j) MIDLINE CHANGE KIT, kit number HSMD20E; k) Minor General, kit number JSMI10I; l) ENDO VASCULAR PACK, kit number LVEV61; m) MAJOR PACK, kit number LVMJ21; n) HEAD AND NECK PACK, kit number MMHN37F; o) KIT, MINOR U BAR, kit number MMNU34E; p) KIT, MAJOR UNIVERSAL, kit number MMUN28E; q) VAG PLASTY PACK, kit number OSVP16; r) DR L MAJOR, kit number SALM40H; s) DR L MAJOR, kit number SALM40I; t) MINOR BASIN SAH, kit number SAMB25E; u) MAJOR SAH, kit number SAMJ36G; v) MINOR PACK, kit number SMMN65; w) General Pack, kit number THGN59D; x) MINOR PACK, kit number TPMN15; y) MAJOR UNIVERSAL PACK, kit number TPUN48

Z-0825-2024
Recall number
Z-0825-2024
Initiated
November 29, 2023
Classification
Class II
Status
Ongoing
Quantity
7881 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the piggybacked components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.

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

During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the piggybacked components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.

Code information

a) AGBR90E, UDI/DI 00191072036865, Lot Numbers: 959231, exp. 02/10/2024; 681221, exp. 11/15/2023; 721221, exp. 09/30/2023; 771221, exp. 08/147/2023; 827221, exp. 06/22/2023; 897221, exp. 04/13/2023; b) AGMM60M, UDI/DI 00191072063786, Lot Numbers: 939231, exp. 03/02/2024; 638221, exp. 4528812/28/2023; 694221, exp. 11/02/2023; 734221, exp. 09/23/2023; 769221, exp. 08/19/2023; c) AHPO55J, UDI/DI 00191072171566, Lot Numbers: 682221, exp. 11/14/2023; 661221, exp. 12/5/2023; 977231, exp. 1/23/2024; 945231, exp. 2/24/2024; 891231, exp. 4/19/2024; d) BBGP31C, UDI/DI none, Lot Numbers: 687221, exp. 11/9/2023; 738221, exp. 9/19/2023; 805221, exp. 7/14/2023; 870221, exp. 5/10/2023; e) FDFT75N, UDI/DI none, Lot Numbers: 773221, exp. 8/15/2023; 714221, exp. 10/13/2023; 990231, exp. 1/10/2024; 935231, exp. 3/6/2024; 890231, exp. 4/20/2024; 870231, exp. 5/10/2024; f) HCAR04K, UDI/DI 00191072114174, Lot Numbers: 757221, exp. 08/31/2023; g) HGBA92F, UDI/DI none, Lot Numbers: 757221, exp. 8/31/2023; 695221, exp. 11/1/2023; 635221, exp. 12/31/2023; h) HNLP12J, UDI/DI 00191072146274, Lot Numbers: 805221, exp. 7/14/2023; 742221, exp. 9/15/2023; 673221, exp. 11/23/2023; 924231, exp. 3/17/2024; i) HSMD20E, UDI/DI 00191072130068, Lot Numbers: 898221, exp. 4/12/2023; 772221, exp. 8/16/2023; 984231, exp. 1/16/2024; j) JSMI10I, UDI/DI none, Lot Numbers: 766221, exp. 08/22/2023; k) LVEV61, UDI/DI 00191072033475, Lot Numbers: 678221, exp. 11/18/2023; 637221, exp. 12/29/2023; l) LVMJ21, UDI/DI 00191072139023, Lot Numbers: 833221, exp. 6/16/2023; 764221, exp. 8/24/2023; 717221, exp. 10/10/2023; 988231, exp. 1/12/2024; 954231, exp. 2/15/2024; m) MMHN37F, UDI/DI none, Lot Numbers: 639221, exp. 12/27/2023; n) MMNU34E, UDI/DI none, Lot Numbers: 928231, exp. 3/13/2024; 889231, exp. 4/21/2024; o) MMUN28E, UDI/DI none, Lot Numbers: 889231, exp. 04/21/2024; p) OSVP16, UDI/DI 00191072156570, Lot Numbers: 827221, exp. 6/17/2023; q) OSVP16, UDI/DI 00191072170835, Lot Numbers: 700221, exp. 10/23/2023; 644221, exp. 12/4/2023; 987231, exp. 11/20/2023; r) SALM40H, UDI/DI none, Lot Numbers: 826221, exp. 6/23/2023; 888221, exp. 4/22/2023; s) SALM40I, UDI/DI none, Lot Numbers: 687221, exp. 11/9/2023; 756221, exp. 9/1/2023; 984231, exp. 1/16/2024; t) SAMB25E, UDI/DI none, Lot Numbers: 843221, exp. 6/6/2023; 894221, exp. 4/16/2023; 871221, exp. 5/9/2023; 686221, exp. 11/10/2023; 758221, exp. 8/30/2023; 793221, exp. 7/26/2023; 974231, exp. 1/26/2024; u) SAMJ36G, UDI/DI none, Lot Numbers: 660221, exp. 12/6/2023; 704221, exp. 10/23/2023; 752221, exp. 9/5/2023; 800221, exp. 7/19/2023; v) SMMN65, UDI/DI 00191072188472, Lot Numbers: 969231, exp. 1/31/2024; 926231, exp. 3/15/2024; w) SMMN65, UDI/DI none, Lot Numbers: 919231, exp. 3/22/2024; x) THGN59D, UDI/DI 00191072191069, Lot Numbers: 805221, exp. 7/14/2023; 721221, exp. 10/6/2023; y) TPMN15, UDI/DI 00191072171771, Lot Numbers: 737221, exp. 9/20/2023; 702221, exp. 10/25/2023; 664221, exp. 12/2/2023; 990231, exp. 1/10/2024; 960231, exp. 2/9/2024; 939231, exp. 3/2/2024; 903231, exp. 4/7/2024; z) TPUN48, UDI/DI 00191072171832, Lot Numbers: 738221, exp. 9/19/2023; 688221, exp. 11/8/2023; 637221, exp. 12/29/2023; 967231, exp. 2/2/2024; 924231, exp. 3/17/2024

Distribution pattern

US Nationwide distribution.

device · product 11 of 18

Custom procedural convenience kits and trays, general hospital use, labeled as: a) Baby PICC Kit, kit number UIBP90J; b) Baby PICC Kit, kit number UIBP90K; c) PORT PACK (PS 058330), kit number UIPO82AB; d) Pediatric PICC Kit, kit number UIPP76K;

Z-0826-2024
Recall number
Z-0826-2024
Initiated
November 29, 2023
Classification
Class II
Status
Ongoing
Quantity
244 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the piggybacked components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.

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

During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the piggybacked components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.

Code information

a) UIBP90J, UDI/DI 00191072117038, Lot Numbers: 996231, exp. 1/4/2024; b) UIBP90K, UDI/DI 00191072189356, Lot Numbers: 911231, exp. 7/26/2023; c) UIPO82AB, UDI/DI 00191072172006, Lot Numbers: 727221, exp. 9/30/2023; 680221, exp. 11/16/2023; d) UIPP76K, UDI/DI 00191072142849, Lot Numbers: 637221, exp. 12/29/2023; 976231, exp. 1/24/2024; 898231, exp. 4/12/2024

Distribution pattern

US Nationwide distribution.

device · product 12 of 18

Custom procedural convenience kits and trays, general hospital use, labeled as: a) IR NEURO PACK, kit number AGNE20J; b) ADULT CRANIOTOMY PACK, kit number LLCR99; c) LAMINECTOMY PACK, kit number LLLC26; d) KIT, CRANIOTOMY, kit number MMCR11J; e) KIT, NEURO SPINE, kit number MMNS20H; f) IR NEURO PACK, kit number OSIN77; g) NEURO SAH, kit number SANE32H; h) NEURO SAH, kit number SANE32I; i) S78FCH CRANI PACK (PS 132432), kit number UICR10U; j) CRANI PACK (PS039498), kit number UICR33AW; k) Laminectomy, kit number UILM77AR; l) DIAGNOSTIC NEURO IR TRAY, kit number WENE21D; m) DIAGNOSTIC NEURO IR TRAY, kit number WENE21F; n) DIAGNOSTIC NEURO IR TRAY, kit number WENE21H; o) DIAGNOSTIC NEURO IR TRAY, kit number WENE21H-01; p) NEURO IR TRAY, kit number WENI56F; q) NEURO IR TRAY, kit number WENI56H; r) NEURO IR TRAY, kit number WENI56H-01

Z-0827-2024
Recall number
Z-0827-2024
Initiated
November 29, 2023
Classification
Class II
Status
Ongoing
Quantity
2717 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the piggybacked components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.

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

During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the piggybacked components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.

Code information

a) AGNE20J, UDI/DI 00191072183187, Lot Numbers: 934231, exp. 10/30/2023; 900231, exp. 4/10/2024; 990231, exp. 1/10/2024; 687221, exp. 11/9/2023; 720221, exp. 10/7/2023; 757221, exp. 8/31/2023; 870221, exp. 5/10/2023; 702221, exp. 10/25/2023; 795221, exp. 7/24/2023; b) LLCR99, UDI/DI 00191072162755, Lot Numbers: 756221, exp. 9/1/2023; 720221, exp. 10/7/2023; 654221, exp. 12/12/2023; 949231, exp. 2/20/2024; c) LLLC26, UDI/DI 00191072171900, Lot Numbers: 749221, exp. 9/8/2023; 695221, exp. 11/1/2023; 997231, exp. 1/3/2024; 920231, exp. 3/21/2024; d) MMCR11J, UDI/DI none, Lot Numbers: 744221, exp. 9/13/2023; 939231, exp. 3/2/2024; 876231, exp. 5/4/2024; e) MMNS20H, UDI/DI none, Lot Numbers: 963231, exp. 2/6/2024; 959231, exp. 2/10/2024; f) OSIN77, UDI/DI 00191072170705, Lot Numbers: 780221, exp. 8/8/2023; 728221, exp. 9/29/2023; 668221, exp. 11/28/2023; 991231, exp. 1/9/2024, 960231, exp. 2/9/2024; 939231, exp. 3/2/2024; UDI/DI 00191072190031, Lot Numbers: 912231, exp. 3/29/2024; 903231, exp. 4/7/2024; g) SANE32H, UDI/DI none, Lot Numbers: 838221, exp. 6/11/2023; 889221, exp. 4/21/2023; h) SANE32I, UDI/DI none, Lot Numbers: 673221, exp. 11/23/2023; 730221, exp. 9/27/2023; 784221, exp. 8/4/2023; 911231, exp. 3/30/2024; 969231, exp. 1/31/2024; i) UICR10U, UDI/DI none, Lot Numbers: 990231, exp. 1/10/2024; 921231, exp. 3/20/2024; 885231, exp. 4/25/2024; j) UICR33AW, UDI/DI none, Lot Numbers: 658221, exp. 12/8/2023; 931231, exp. 3/10/2024; 876231, exp. 5/4/2024; k) UILM77AR, UDI/DI 00191072139184, Lot Numbers: 953231, exp. 2/16/2024; 905231, exp. 4/5/2024; l) WENE21D, UDI/DI 00191072167958, Lot Numbers: 839221, exp. 6/10/2023; m) WENE21F, UDI/DI 00191072167958, Lot Numbers: 819221, exp. 6/30/2023; n) WENE21H, UDI/DI 00191072179326, Lot Numbers: 729221, exp. 9/28/2023; 686221, exp. 11/10/2023; o) WENE21H-01, UDI/DI 00191072179326, Lot Numbers: 980231, exp. 1/20/2024; p) WENI56F, UDI/DI 00191072169341, Lot Numbers: 799221, exp. 7/20/2023; q) WENI56H, UDI/DI 00191072179333, Lot Numbers: 700221, exp. 10/27/2023; r) WENI56H-01, UDI/DI 00191072179333, Lot Numbers: 652221, exp. 12/14/2023; 996231, exp. 1/4/2024

Distribution pattern

US Nationwide distribution.

device · product 13 of 18

Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LOWER PELVIC PACK, kit number AGLP52L; b) OB/GYN DAVINCI PACK A RG BASIN, kit number HGOB98G; c) DAVINCI GYN PACK, kit number HHDV17; d) KIT, GYNE ROBOTIC, kit number MMGR44D; e) KIT, MAJOR LITHOTOMY, kit number MMJL16E; f) GYN PACK, kit number SMGY46; g) Lithotomy Pack, kit number THLH71C; h) ASC HYSTEROSCOPY PACK (PS 020634), kit number UIHY16AA; i) GYN LAPAROSCOPY HPES, kit number WELP67C; j) GYN LAPAROSCOPY HPES, kit number WELP67C-01; k) GYN LAPAROSCOPY HPES, kit number WELP67C-02

Z-0828-2024
Recall number
Z-0828-2024
Initiated
November 29, 2023
Classification
Class II
Status
Ongoing
Quantity
1020 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the piggybacked components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.

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

During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the piggybacked components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.

Code information

a) AGLP52L, UDI/DI 00191072144119, Lot Numbers: 933231, exp. 3/8/2024; 942231, exp. 2/27/2024; 947231, exp. 2/22/2024; 966231, exp. 2/3/2024; 980231, exp. 1/20/2024; 681221, exp. 11/15/2023; 707221, exp. 10/20/2023; b) HGOB98G, UDI/DI none, Lot Numbers: 667221, exp. 11/29/2023; 977231, exp. 1/23/2024; 952231, exp. 1/31/2024; 896231, exp. 1/31/2024; c) HHDV17, UDI/DI 00191072170125, Lot Numbers: 766221, exp. 8/22/2023; 731221, exp. 9/26/2023; 682221, exp. 11/14/2023; 638221, exp. 12/28/2023; 946231, exp. 2/23/2024; d) MMGR44D, UDI/DI none, Lot Numbers: 709221, exp. 10/18/2023; 650221, exp. 12/16/2023; 891231, exp. 4/19/2024; e) MMJL16E, UDI/DI none, Lot Numbers: 989231, exp. 1/11/2024; 920231, exp. 3/21/2024; f) SMGY46, UDI/DI 00191072188458, Lot Numbers: 961231, exp. 2/8/2024; g) THLH71C, UDI/DI 00191072155108, Lot Numbers: 756221, exp. 9/1/2023; 708221, exp. 10/19/2023; h) UIHY16AA, UDI/DI none, Lot Numbers: 931231, exp. 3/10/2024; 896231, exp. 4/14/2024; i) WELP67C, UDI/DI 00191072173676, Lot Numbers: 751221, exp. 9/6/2023; 681221, exp. 9/13/2023; j) WELP67C-01, UDI/DI 00191072173676, Lot Numbers: 720221, exp. 9/21/2023; k) WELP67C-02, UDI/DI 00191072173676, Lot Numbers: 643221, exp. 9/13/2023

Distribution pattern

US Nationwide distribution.

device · product 14 of 18

Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LABOR & DELIVERY PACK, kit number HILD52F; b) LABOR & DELIVERY PACK, kit number HILD52G

Z-0829-2024
Recall number
Z-0829-2024
Initiated
November 29, 2023
Classification
Class II
Status
Ongoing
Quantity
114 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the piggybacked components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.

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

During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the piggybacked components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.

Code information

a) HILD52F, UDI/DI none, Lot Numbers: 846221, exp. 6/3/2023; 807221, exp. 7/12/2023; 959231, exp. 11/30/2023; b) HILD52G, UDI/DI none, Lot Numbers: 885231, exp. 4/25/2024

Distribution pattern

US Nationwide distribution.

device · product 15 of 18

Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) C-SECTION PACK, kit number FDCS01AA; b) C-SECTION PACK, kit number FDCS01AB; c) C-SECTION STERILE PACK, kit number HGCS68J; d) C-SECTION PACK, kit number HICS50H; e) C-SECTION PPS, kit number LLCI66; f) C-Section drape Pack, kit number RBCS12R; g) C-Section, kit number THCS49B; h) C-SECTION PACK (PS 020632), kit number UICS50AG;

Z-0830-2024
Recall number
Z-0830-2024
Initiated
November 29, 2023
Classification
Class II
Status
Ongoing
Quantity
1818 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the piggybacked components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.

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

During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the piggybacked components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.

Code information

a) FDCS01AA, UDI/DI 00191072179890, Lot Numbers: 708221, exp. 10/23/2023; 646221, exp. 12/20/2023; b) FDCS01AB, UDI/DI 00191072185273, Lot Numbers: 886231, exp. 4/24/2024; c) HGCS68J, UDI/DI none, Lot Numbers: 702221, exp. 10/22/2023; 654221, exp. 12/12/2023; 960231, exp. 2/9/2024; 903231, exp. 4/7/2024; d) HICS50H, UDI/DI none, Lot Numbers: 909221, exp. 4/1/2023; 835221, exp. 6/14/2023; 755221, exp. 9/2/2023; e) LLCI66, UDI/DI 00191072119025, Lot Numbers: 750221, exp. 9/7/2023; 727221, exp. 9/30/2023; 678221, exp. 11/9/2023; 994231, exp. 11/9/2023; 948231, exp. 11/9/2023; 926231, exp. 11/9/2023; f) RBCS12R, UDI/DI 00191072131812, Lot Numbers: 770221, exp. 8/18/2023; 695221, exp. 11/1/2023; g) THCS49B, UDI/DI 00191072153357, Lot Numbers: 770221, exp. 8/18/2023; h) UICS50AG, UDI/DI none, Lot Numbers: 679221, exp. 11/17/2023; 946231, exp. 2/23/2024; 876231, exp. 5/4/2024;

Distribution pattern

US Nationwide distribution.

device · product 16 of 18

Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LavH, kit number BBLV21C; b) LAP HYST 247540, kit number BFHY75U

Z-0831-2024
Recall number
Z-0831-2024
Initiated
November 29, 2023
Classification
Class II
Status
Ongoing
Quantity
144 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the piggybacked components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.

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

During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the piggybacked components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.

Code information

a) BBLV21C, UDI/DI none, Lot Numbers: 686221, exp. 11/10/2023; 791221, exp. 7/28/2023; 841221, exp. 6/8/2023; b) BFHY75U, UDI/DI 00191072169839, Lot Numbers: 878231, exp. 5/2/2024; 933231, exp. 3/8/2024; 987231, exp. 11/30/2023; 659221, exp. 12/7/2023; 689221, exp. 11/7/2023

Distribution pattern

US Nationwide distribution.

device · product 17 of 18

Custom procedural convenience kits and trays, Ophthalmic use, labeled as: a) EYE PACK, kit number LVEY27; b) Laminectomy, kit number UIOL34AG

Z-0832-2024
Recall number
Z-0832-2024
Initiated
November 29, 2023
Classification
Class II
Status
Ongoing
Quantity
940 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the piggybacked components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.

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

During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the piggybacked components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.

Code information

a) LVEY27, UDI/DI 00191072135728, Lot Numbers: 840221, exp. 6/29/2023; 771221, exp. 8/17/2023; 715221, exp. 10/12/2023; 982231, exp. 1/18/2024; 917231, exp. 3/24/2023; b) UIOL34AG, UDI/DI 00191072191168, Lot Numbers: 912231, exp. 3/29/2024; 898231, exp. 4/12/2024

Distribution pattern

US Nationwide distribution.

device · product 18 of 18

Custom procedural convenience kits and trays, Othopedic use, labeled as: a) HIP FRACTURE, kit number AHHF15C; b) HIP FRACTURE, kit number AHHF15D; c) Hand Pack, kit number BBHP10E; d) Lower Extremity, kit number BBLE40B; e) Custom Podiatry, kit number BOCP70J; f) ROBOTIC PACK, kit number BPAR65A; g) HIP PINNING PACK, kit number EMHP84; h) HIP PINNING PK, STRL F G, kit number FHHI17V; i) TOTAL HIP PACK, kit number GNTH06L; j) TOTAL KNEE PACK, kit number GNTK07L; k) EXTREMITY PACK, kit number GUEX48I; l) MAJOR ORTHO PACK, kit number GUMO40J; m) TOTAL KNEE ACCESS PACK, kit number HITK58D; n) SHOULDER ARTHROSCOPY, kit number HNSH17H; o) TOTAL HIP PACK, kit number HNTH76M; p) TOTAL KNEE PACK, kit number HNTK81M; q) ORIF HIP PACK, kit number HOHP28; r) DR. GREENWALD TOTAL KNEE, kit number HSGK80S; s) Custom Lower Ext, kit number JSLE08E; t) HAND PACK, kit number LVHD29; u) KIT, LOWER EXTREMITY, kit number MMEX19E; v) KIT, HIP PINNING, kit number MMHP45E; w) KIT, ORTHO SPINE, kit number MMSP21H; x) KIT, TOTAL HIP, kit number MMTH15E; y) KIT, TOTAL KNEE, kit number MMTK66E; z) KIT, UPPER EXTREMITY OPEN SHOULDER, kit number MMUE31E; aa) HIP SCOPE, kit number PTHS10D; bb) HIP SCOPE, kit number PTHS10F; cc) SHOULDER ARTHROSCOPY SAH, kit number SASA18D; dd) SHOULDER ARTHROSCOPY SAH, kit number SASA18F; ee) TOTAL ORTHO SAH, kit number SATO27F; ff) TOTAL ORTHO SAH, kit number SATO27G; gg) PODIATRY PACK, kit number SMPD35; hh) SHOULDER PACK, kit number SMSH12; ii) MAJOR SETUP PACK, kit number SMSU17A; jj) TOTAL HIP, kit number SMTH39; kk) TOTAL KNEE, kit number SMTK21; ll) Knee Arthroscopy, kit number SPKA57Q; mm) SHOULDER ARTHROSCOPY, kit number SPSA58P; nn) Total Hip pack W-O Stryker, kit number SPTH50AF; oo) Total Knee pack W-O Stryker, kit number SPTK51AF; pp) UPPER EXTREMITY, kit number SRUE05M; qq) Arthroscopy Pack, kit number THAR35B; rr) Extremity Pack, kit number THEX27B ss) Shoulder Pack, kit number THSH07F tt) Total Joint, kit number THTJ22G uu) TOTAL HIP PACK, kit number WHTH07D vv) TOTAL HIP PACK, kit number WHTH07E ww) TOTAL KNEE, kit number WHTK06C xx) TOTAL KNEE, kit number WHTK06D yy) CARPAL TUNNEL WEXFORD PACK, kit number WXCT12E

Z-0833-2024
Recall number
Z-0833-2024
Initiated
November 29, 2023
Classification
Class II
Status
Ongoing
Quantity
5524 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the piggybacked components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.

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

During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the piggybacked components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.

Code information

a) AHHF15C, UDI/DI 00191072137524, Lot numbers: 696221, exp. 9/7/2023; 741221, exp. 9/16/2023; 787221, exp. 8/1/2023; 873221, exp. 5/7/2023; b) AHHF15D, UDI/DI 00191072183552, Lot numbers: 890231, exp. 4/21/2024; 959231, exp. 2/10/2024; 652221, exp. 9/5/2023; c) BBHP10E, UDI/DI none, Lot numbers: 678221, exp. 11/18/2023; 748221, exp. 9/9/2023; 811221, exp. 7/8/2023; 867221, exp. 5/13/2023; 969231, exp. 1/31/2024; d) BBLE40B, UDI/DI none, Lot numbers: 679221, exp. 11/17/2023; 743221, exp. 9/14/2023; e) BOCP70J, UDI/DI none, Lot numbers: 705221, exp. 10/22/2023; 747221, exp. 9/10/2023; 839221, exp. 6/10/2023; f) BPAR65A, UDI/DI 00191072187444, Lot numbers: 960231, exp. 2/9/2024; g) EMHP84, UDI/DI 00191072094650, Lot numbers: 934231, exp. 9/30/2023; 983231, exp. 10/26/2023; 678221, exp. 9/30/2023; 769221, exp. 8/19/2023; 805221, exp. 7/14/2023; 856221, exp. 5/24/2023; 891221, exp. 4/19/2023; h) FHHI17V, UDI/DI none, Lot numbers: 708221, exp. 10/19/2023; 651221, exp. 12/15/2023; 939231, exp. 3/2/2024; 885231, exp. 4/25/2024; i) GNTH06L, UDI/DI 00191072157416, Lot numbers: 896221, exp. 4/14/2023; 778221, exp. 8/10/2023; j) GNTK07L, UDI/DI none, Lot numbers: 715221, exp. 10/12/2023; 974231, exp. 1/26/2024; k) GUEX48I, UDI/DI none, Lot numbers: 680221, exp. 11/16/2023; 639221, exp. 12/27/2023; 981231, exp. 1/19/2024; 927231, exp. 3/14/2024; l) GUMO40J, UDI/DI none, Lot numbers: 715221, exp. 10/12/2023; 638221, exp. 12/28/2023; 975231, exp. 1/25/2024; 893231, exp. 4/17/2024; m) HITK58D, UDI/DI none, Lot numbers: 773221, exp. 8/15/2023; 717221, exp. 10/10/2023; 991231, exp. 1/9/2024; 935231, exp. 3/6/2024; n) HNSH17H, UDI/DI none, Lot numbers: 741221, exp. 9/16/2023; 989231, exp. 1/11/2024; 949231, exp. 2/20/2024; o) HNTH76M, UDI/DI none, Lot numbers: 848221, exp. 6/1/2023; 702221, exp. 10/25/2023; 980231, exp. 1/20/2024; p) HNTK81M, UDI/DI none, Lot numbers: 731221, exp. 9/26/2023; 689221, exp. 11/7/2023; 966231, exp. 2/3/2024; q) HOHP28, UDI/DI 00191072171009, Lot numbers: 724221, exp. 10/3/2023; 687221, exp. 11/9/2023; 990231, exp. 1/10/2024; 942231, exp. 2/27/2024; r) HSGK80S, UDI/DI none, Lot numbers: 689221, exp. 11/7/2023; 668221, exp. 11/28/2023; 969231, exp. 1/31/2024; 932231, exp. 9/3/2024; 871231, exp. 5/9/2024; s) JSLE08E, UDI/DI 00191072135773, Lot numbers: 895221, exp. 4/15/2023; t) LVHD29, UDI/DI 00191072062512, Lot numbers: 737221, exp. 9/20/2023; 716221, exp. 10/11/2023; 681221, exp. 11/15/2023; 650221, exp. 12/16/2023; 989231, exp. 1/11/2024; 942231, exp. 2/27/2024; u) MMEX19E, UDI/DI none, Lot numbers: 966231, exp. 2/3/2024; 893231, exp. 4/17/2024; v) MMHP45E, UDI/DI none, Lot numbers: 879231, exp. 5/1/2024; w) MMSP21H, UDI/DI none, Lot numbers: 927231, exp. 3/14/2024; x) MMTH15E, UDI/DI none, Lot numbers: 688221, exp. 11/8/2023; 654221, exp. 12/12/2023; 968231, exp. 2/1/2024; y) MMTK66E, UDI/DI none, Lot numbers: 680221, exp. 11/16/2023; 991231, exp. 1/9/2024; z) MMUE31E, UDI/DI none, Lot numbers: 919231, exp. 3/22/2024; aa) PTHS10D, UDI/DI 00191072131362, Lot numbers: 646221, exp. 12/20/2023; 675221, exp. 9/5/2023; 720221, exp. 10/7/2023; 778221, exp. 8/10/2023; bb) PTHS10F, UDI/DI 00191072131362, Lot numbers: 918231, exp. 9/5/2023; 984231, exp. 1/16/2024; cc) SASA18D, UDI/DI none, Lot numbers: 885221, exp. 4/25/2023; dd) SASA18F, UDI/DI none, Lot numbers: 663221, exp. 12/3/2023; 701221, exp. 10/26/2023; 726221, exp. 10/012023; 800221, exp. 7/19/2023; 981231, exp. 1/19/2024; ee) SATO27F, UDI/DI none, Lot numbers: 833221, exp. 6/16/2023; 870221, exp. 5/10/2023; ff) SATO27G, UDI/DI none, Lot numbers: 652221, exp. 12/14/2023; 695221, exp. 11/1/2023; 722221, exp. 10/5/2023; 756221, exp. 9/1/2023; 7912210, exp. 7/28/2023; 925231, exp. 3/16/2024; 954321, exp. 2/15/2024; 989231, exp. 1/11/2024; gg) SMPD35, UDI/DI 00191072188496, Lot numbers: 961231, exp. 2/8/2024; hh) SMSH12, UDI/DI 00191072188502, Lot numbers: 970231, exp. 1/30/2024; 899231, exp. 4/11/2024; ii) SMSU17A, UDI/DI 00191072188519, Lot numbers: 938231, exp. 3/3/2024; 918231, exp. 3/23/2024; jj) SMTH39, UDI/DI 00191072188526, Lot numbers: 961231, exp. 2/8/2024; 928231, exp. 3/13/2024; kk) SMTK21, UDI/DI 00191072188533, Lot numbers: 968231, exp. 2/1/2024; 928231, exp. 3/13/2024; ll) SPKA57Q, UDI/DI 00191072163479, Lot numbers: 773221, exp. 8/15/2023; 707221, exp. 10/20/2023; mm) SPSA58P, UDI/DI 00191072105264, Lot numbers: 775221, exp. 8/13/2023; 706221, exp. 10/21/2023; nn) SPTH50AF, UDI/DI 00191072163448, Lot numbers: 833221, exp. 6/16/2023; 797221, exp. 7/22/2023; oo) SPTK51AF, UDI/DI 00191072163486, Lot numbers: 709221, exp. 10/18/2023; 702221, exp. 10/25/2023; pp) SRUE05M, UDI/DI 00191072185761, Lot numbers: 878231, exp. 5/2/2024; qq) THAR35B, UDI/DI 00191072153340, Lot numbers: 708221, exp. 10/19/2023; 701221, exp. 10/26/2023; rr) THEX27B, UDI/DI 00191072166074, Lot numbers: 778221, exp. 8/10/2023; 687221, exp. 11/9/2023; ss) THSH07F, UDI/DI 00191072163493, Lot numbers: 791221, exp. 7/28/2023; 741221, exp. 9/16/2023; tt) THTJ22G, UDI/DI 00191072189889, Lot numbers: 716221, exp. 10/11/2023; 708221, exp. 10/19/2023; uu) WHTH07D, UDI/DI none, Lot numbers: 693221, exp. 11/3/2023; 730221, exp. 9/27/2023; 772221, exp. 8/16/2023; 804221, exp. 7/15/2023; 856221, exp. 5/24/2023; vv) WHTH07E, UDI/DI none, Lot numbers: 646221, exp. 12/20/2023; 933231, exp. 3/18/2024; 969231, exp. 1/31/2024; 991231, exp. 1/9/2024; ww) WHTK06C, UDI/DI none, Lot numbers: 709221, exp. 10/18/2023; 766221, exp. 8/22/2023; 806221, exp. 7/13/2023; 861221, exp. 5/19/2023; xx) WHTK06D, UDI/DI none, Lot numbers: 654221, exp. 12/12/2023; 966231, exp. 2/3/2023; yy) WXCT12E, UDI/DI 00191072053671, Lot numbers: 959231, exp. 2/10/2024; 696221, exp. 10/31/2023; 703221, exp. 10/24/2023; 731221, exp. 9/26/2023; 786221, exp. 8/2/2023; 862221, exp. 5/18/2023;

Distribution pattern

US Nationwide distribution.