Safeguard US Operating LLC

Huntersville, NC, US

SAFEGUARD US OPERATING, LLC appears in FDA device records in Huntersville, NC. FDA records list 3 510(k) clearances between 2010-08-11 and 2015-01-26, no PMA records and one registered establishment. As of 2026-09-10, FDA records show 8 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 3
PMA records: 0
Recall records: 8
Registered establishments: 1

FDA records under these names

1 name

FDA records resolved to Safeguard US Operating LLC carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

Combat Medical Systems, LLC510(k), enforcement report, recall

510(k) clearance history

FDA records hold 3 510(k) clearances for Safeguard US Operating LLC between 2010 and 2015. The busiest year on record is 2010, with 1. The most recent is 2015, with 1.

Clearances by year, as a table

510(k) clearance decisions for Safeguard US Operating LLC, by decision year
Year	Clearances
2010	1
2013	1
2015	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K141685	CROC	DXC	Substantially Equivalent	2015-01-26
K130482	COMBAT READY CLAMP	DXC	Substantially Equivalent	2013-04-29
K102025	COMBAT READY CLAMP	DXC	Substantially Equivalent	2010-08-11

Registered establishments

FDA registered establishments for Safeguard US Operating LLC, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3008258694	3008258694	SAFEGUARD US OPERATING, LLC	13359 Reese Blvd. E, Huntersville, NC 28078 US	2026	BSB BTL BTQ BZO CAI DXC FPP FPY FQM GAA and 24 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-3183-2024	Kits of Convenience containing 1 of the 2 Item Numbers: 1. Item Number: 59-300 HAWK Warming Grid, 2. Item Number: 59-320 HAWK Advanced Hypothermia Management Set. Convenience kits labeled as follows: Combat Life Saver - Intermediate (Product Number: 83-323-CB) contains 59-300 / 1 Each; Medic Enhancement Resupply (Product Number: 82-504-05) contains 59-300 / 1 Each; Combat Life Saver - Advanced (Product Number: 83-325-CB) contains 59-300 / 1 Each; Cold Weather (Product Number: 82-505) contains 59-300 / 1 Each; HAWK w/ Carrier Set, Multicam, Stocked (Product Number: 83-315-01-MC) contains 59-300 / 1 Each; Mojo Combat Life Saver - Intermediate - Multicam (Product Number: 83-323-MC); Combat Life Saver - Intermediate - Multicam (Product Number: 83-323-MC); Mojo Combat Life Saver - Advanced - Multicam (Product Number: 83-325-MC); DIRECT ACTION BAG, FOLIAGE GREEN, ADVANCED, STOCKED (Product Number: 84-497-FG).	Incorrect expiration date.	Class II	2024-08-27	Open, Classified
Z-3182-2024	HAWK Advanced Hypothermia Management Set, Item Number: 59-320	Incorrect expiration date.	Class II	2024-08-27	Open, Classified
Z-3181-2024	HAWK Warming Grid, Item Number: 59-300	Incorrect expiration date.	Class II	2024-08-27	Open, Classified
Z-1114-2021	Fresh Whole Blood Donor Set (P/N 80-801-D NSN 6515016640306) . Blood convenience kit. The Fresh Whole Blood Doner Set contains everything needed to test for ABO/Rh compatibility and collect the whole blood from donor.	There is the potential of a bent or disconnected needle in one of the components of the convenience kits.	Class I	2020-12-23	Terminated
Z-1113-2021	Fresh Whole Blood Transfusion Set (P/N 80-801 NSN 6515016574750) . Blood convenience kit. The Fresh Whole Blood Transfusion Set contains everything needed to test for ABO/Rh compatibility and perform a fresh whole blood transfusion in a compact sealed package.	There is the potential of a bent or disconnected needle in one of the components of the convenience kits.	Class I	2020-12-23	Terminated
Z-1112-2021	Low Titer Type O FWB Transfusion Set (P/N 80-875 NSN 651501684994). Blood convenience kit. The Transfusion Set includes the items necessary to administer the collected blood to a patient.	There is the potential of a bent or disconnected needle in one of the components of the convenience kits.	Class I	2020-12-23	Terminated
Z-1111-2021	Valkyrie LTOWB Administration (P/N 80-821 NSN 6515016862401). Blood convenience kit. The Valkyrie LTOWB Administration Set contains the items needed to administer the blood to the patient.	There is the potential of a bent or disconnected needle in one of the components of the convenience kits.	Class I	2020-12-23	Terminated
Z-1110-2021	Valkyrie LTOWB Collection (P/N 80-820, NSN 6515016862423). Blood collection convenience kit. The Valkyrie LTOWB Collection Set includes the items needed to allow for pre-screening to identify Low Titer Type O Donors as well as collect the blood from the donor.	There is the potential of a bent or disconnected needle in one of the components of the convenience kits.	Class I	2020-12-23	Terminated

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain