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Product Description
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Recall Class
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FDA Recall Posting Date
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Recalling Firm
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Z-0830-2024 - 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 P...
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2
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01/26/2024
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American Contract Systems, Inc.
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Z-0828-2024 - 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) D...
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2
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01/26/2024
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American Contract Systems, Inc.
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Z-0829-2024 - 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
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2
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01/26/2024
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American Contract Systems, Inc.
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Z-0831-2024 - Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as:
a) LavH, kit number BBLV21C;
b) LAP HYST 247540, kit number BFHY75U
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2
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01/26/2024
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American Contract Systems, Inc.
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Z-0832-2024 - Custom procedural convenience kits and trays, Ophthalmic use, labeled as:
a) EYE PACK, kit number LVEY27;
b) Laminectomy, kit number UIOL34AG
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2
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01/26/2024
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American Contract Systems, Inc.
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Z-0833-2024 - 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 E...
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2
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01/26/2024
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American Contract Systems, Inc.
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Z-0816-2024 - 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
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2
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01/26/2024
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American Contract Systems, Inc.
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Z-0819-2024 - 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) Pediatri...
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2
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01/26/2024
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American Contract Systems, Inc.
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Z-0817-2024 - 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;
...
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2
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01/26/2024
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American Contract Systems, Inc.
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Z-0820-2024 - 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 MMTA4...
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2
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01/26/2024
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American Contract Systems, Inc.
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