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SuctionShield

PATIENT SHIELD CONCEPTS, LLC · Model PSC5300 · UDI-DI 00861283000312

JOL Prescription

510(k) clearances

2,781

Adverse events (16 deaths)

Recalls

334

Facilities

Description

The holster device provides safe and convenient storage of the Yankauer Suction Tip between suctions of the individual patient. It is designed to avoid contamination of the individual patient's suction tip by preventing contact of the tip with any surface other than the patient's own disposable holster or cross contamination of other patients and healthcare personnel. The device is a disposable, plastic, wide mouthed receptacle, intended to be attached to the patient's bed rail.

Recalls

Date	Firm	Reason
2026-03-05	Cook Incorporated	Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
2026-03-05	Cook Incorporated	Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
2026-01-07	Medline Industries, LP	Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag
2026-01-07	Medline Industries, LP	Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag
2024-06-11	Merit Medical Systems, Inc.	Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that ma
2023-12-04	Cardinal Health 200, LLC	Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
2023-11-15	MEDLINE INDUSTRIES, LP - Northfield	Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile
2023-05-18	MEDLINE INDUSTRIES, LP - Northfield	Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
2019-09-17	Cook Inc.	Lidstock perforation line may be over the sterile area of the tray, when it should be on the lip of the tray, potentially compromising the sterility of the device.
2019-06-10	Santanello Surgical LLC	Lack of package integrity may compromise sterility

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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.