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Devices
Procedure Kits
Model / Serial
Lot Numbers: H992344 and H996476
Product Classification
General and Plastic Surgery Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide to VA, UT, and NC. Other foreign consignee Japan. No Canadian and VA/govt/military consignees.
Product Description
Procedure Kit. Catalog Numbers K12-04830B and K12-YP030A
Manufacturer
Merit Medical Systems, Inc.
1 Event
Recall of Procedure Kits
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Manufacturer
Merit Medical Systems, Inc.
Manufacturer Address
Merit Medical Systems, Inc., 1600 W Merit Pkwy, South Jordan UT 84095-2416
Manufacturer Parent Company (2017)
Merit Medical Systems Inc.
Source
USFDA
44 devices with a similar name
Learn more about the data
here
Propax Procedure Kits containing Devon Light Gloves
Model / Serial
Model: 2900456-0x, 2900846-0x, 2901816-0x, 2902500-0x, 2903916-0x, 2904409-0x, 2906757-00, 2908159-0x, 2908973-0x, Affected: All lot numbers ending xx2, xx3, xx4, and lot numbers 015, 025, 035, and 045 delivered before 6 May 2015
Manufacturer
BSN Medical Ltd
Medline Custom Procedure Kits
Model / Serial
Model: 571711, Affected: multiple pack codes
Manufacturer
Medline Assembly Australia Pty Ltd
Medline Custom Procedure Kits Class 2b
Model / Serial
Model: , Affected: SENNZAH03 Oral Health, SNENZMN01 Spin Pack, SENNZOR01 Dental Pack
Manufacturer
Medline Assembly Australia Pty Ltd
Medline Custom Procedure Kits Class 2b
Model / Serial
Model: , Affected: CS1672744, CS1672725, CS1672725, CS1672725, CS1671553, CS1672725, CS1672725, CS1672750, CS1671552
Manufacturer
Medline Assembly Australia Pty Ltd
BSN Propax - Surgical procedure kits
Model / Serial
Model: , Affected: 046, 056, 076, 096, 106 116 066, 086
Manufacturer
BSN Medical Ltd
39 more
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