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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-0818-2024 - 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...
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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-0823-2024 - 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;
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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-0827-2024 - 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 numbe...
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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-0826-2024 - 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 ...
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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-0824-2024 - Custom procedural convenience kits and trays, general & plastic surgery, labeled as:
a) Breast Plastics Pack, kit number BBPL20D;
b) MINOR PLASTIC, kit number WPMP16H
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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-0825-2024 - 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)...
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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-0822-2024 - 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) L...
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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-0821-2024 - Custom procedural convenience kits and trays, gastroenterological & urological, labeled as:
AHN BIOPSY STERILE, kit number AHBP12A
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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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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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