Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700RE Software Versi

FDA device recall Z-1115-2026 · posted 2026-01-28 · Open, Classified

Recall details

Recalling firm

SunMed Holdings, LLC

Reason for recall

Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.

Action taken

AirLife issued an URGENT: MEDICAL DEVICE RECALL NOTICE to its consignees on 12/15/2025 via email and US mail. The notice explained the issue, potential risk to the patient, and requested the following: "Customer immediate actions: Please take the following actions immediately: 1. Stop using the affected tapes o Immediately discontinue use of all AirLife Broselow Rainbow Tapes identified as 2025 Edition, 36-23446 Rev 3 Print Version. 2. Identify and segregate affected product o Examine your inventory and clinical areas for affected Broselow Rainbow Tapes (see Image B for identifying characteristics). o Remove all affected tapes from clinical service. o Segregate or quarantine the affected tapes to prevent further use. 3. Follow disposition instructions o Follow the instructions provided in the accompanying communication regarding discarding/destruction of the affected tapes. o Do not redistribute or place any affected tapes back into service. 4. Notify your internal users o Ensure that all clinicians and healthcare professionals within your organization who may use the Broselow Rainbow Tape are informed of this recall/field removal and understand that the affected Rev 3 tapes must not be used. 5. Notify downstream customers (if applicable) o If you have further distributed the affected tapes, please identify your customers/consignees and notify them of this recall/field removal promptly. o Your notification may be enhanced by including a copy of this letter. o If you have impacted product on hand, do not ship it; instead, hold it for discarding/destruction as instructed. 6. Complete and return the Response Form o Please complete and return the attached Response Form via e-mail to productquality@myairlife.com as soon as possible. Please complete and return Attachment B if you have affected product for discarding/destruction. This allows us to document your receipt of this recall notice and the status of affected product at

Root cause

Device Design

Status

Open, Classified

Product code

OKI

Quantity affected

20583

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Singapore.

Date initiated

2025-12-15

Date posted

2026-01-28

Location

Grand Rapids, MI