| Date Initiated by Firm | December 15, 2025 |
|---|
| Date Posted | January 28, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1117-2026 |
|---|
| Recall Event ID |
98208 |
| Product Classification |
Emergency response safety kit - Product Code OKI
|
| Product | Brand Name: Broselow
Product Name: BROSELOW" FILLED BROSELOW ORGANIZER
Model/Catalog Number: 7730IALS
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 |
|---|
| Code Information |
Lot Code: Lot/Serial Number(s)
0004317699
0004333171
0004333593
UDI-DI
Each-10889483589205
Case-30889483589209
|
Recalling Firm/
Manufacturer |
SunMed Holdings, LLC
2710 Northridge Dr Nw Ste A
Grand Rapids MI 49544-9112
|
| For Additional Information Contact | Jessica Hoke
1-616-2598400 |
|---|
Manufacturer Reason
for Recall | Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine. |
|---|
FDA Determined
Cause 2 | 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 in Commerce | 89 |
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| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Singapore. |
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| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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