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Puregraft Instrument Set

Bimini Technologies LLC · Model 550/IS SST · UDI-DI 00850034511030

MDM Prescription

510(k) clearances

4,164

Adverse events (4 deaths)

Recalls

841

Facilities

Description

Is composed of the Puregraft Easel and Puregraft Slider. Both components are made of autoclavable stainless steel. The Easel holds the Puregraft Bag in place, and the Slider tool is used on the exterior of the Puregraft Bag to compress and facilitate the movement of liquids through the filter mesh and into the Drain Bag.

Recalls

Date	Firm	Reason
2025-03-03	MEDLINE INDUSTRIES, LP - Northfield	There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
2024-12-03	Sklar Instruments	Reports of various packaging issues that may result in a breach of the sterile barrier.
2024-02-23	MEDLINE INDUSTRIES, LP - Northfield	Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
2024-01-31	Technicality Inc.	The Ring on the Trump Needle Guide can detach when excessive pressure is applied.
2024-01-30	Applied Medical Resources Corp	Their is the potential that Universal Clip applier may not load clip after the trigger is actuated.
2024-01-30	Applied Medical Resources Corp	Their is the potential that Universal Clip applier may not load clip after the trigger is actuated.
2022-11-17	MEDLINE INDUSTRIES, LP - Northfield	Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
2022-11-08	ENDO Pharmaceuticals Solutions, Inc.	No expiration dates printed on the packaging
2022-11-02	Arthrex, Inc.	The devices may be packaged with the wrong reamer size.
2021-12-22	FlexDex Inc.	The firm is reinforcing the IFU instructions: "Do not use if the package is damaged." If upon inspection of the packaging, any damage is observed, including pinholes or tears in th

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.