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5437 Bandages and Supplies

SIGVARIS INC · Model 5437 · UDI-DI 00745129304560

FQM FMP

510(k) clearances

297

Adverse events

Recalls

698

Facilities

Description

Inelastic garment (or accessory) made of nylon and polyester which functions to increase the working pressure applied to the affected limb by providing consistent, firm pressure. Can be used throughout the phases of decongestive therapy to reduce swelling and shape the limb. Available with or without a prescription. Its important to note that specific therapy or approaches used for lymphedema management should be tailored by the healthcare provider. This is a reusable, washable device.

Recalls

Date	Firm	Reason
2026-02-27	Medline Industries, LP	Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
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.
2024-04-08	MEDLINE INDUSTRIES, LP - Northfield	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
2024-04-02	Andover Healthcare Inc.	A packaging seal gap could impact the sterility of the product.
2022-06-22	ASO LLC	The product falls apart during handling after removal from its primary packaging.
2022-05-25	Mckesson Medical-Surgical Inc. Corporate Office	Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0
2022-02-01	BSN Medical Inc	The folding boxes within the shipping case are mislabeled. The shipping case and immediate packages within the folding boxes are correctly labeled.
2020-08-21	North American Rescue LLC.	Lack of sterility assurance of the 30-0171
2019-06-19	Andover Healthcare Inc.	Incomplete packaging seal of sterile product
2019-06-19	Andover Healthcare Inc.	Incomplete packaging seal of sterile product

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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.