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Open, Classified

Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700REA 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

FDA Recall Z-1114-2026 · Posted 2026-01-28

Recalling FirmSunMed Holdings, LLC
Recall StatusOpen, Classified
Product CodeOKI
Date Initiated2025-12-15
Product Quantity95300

Reason for Recall

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

Firm 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 [email protected] 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

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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