SunMed Holdings, LLC: Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700RE Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care. Component: No

Recall number

Z-1115-2026

Recalling firm

SunMed Holdings, LLC

Product

Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700RE Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care. Component: No

Status

Open, Classified

Initiated

2025-12-15

Posted

2026-01-28

Terminated

not on file

Reason

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

Root cause

Device Design

Action

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

Quantity

20583

Distribution

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

Lot, serial or model codes

Lot Code: Lot/Serial Number(s) 0004325583 0004329077 0004329078 0004329079 0004331255 0004333368 0004335537 0004338439 0004340824 UDI-DI Each-10889483588963 Case-30889483588967

510(k) numbers

not on file

PMA numbers

not on file

Product code

OKI

Firm FEI

1314417

Firm city

Grand Rapids

Firm state

MI

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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