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U.S. Department of Health and Human Services

Class 1 Device Recall AirLife Broselow Pediatric Emergency Rainbow Tape

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 Class 1 Device Recall AirLife Broselow Pediatric Emergency Rainbow Tapesee related information
Date Initiated by FirmMay 15, 2025
Date PostedJune 20, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1904-2025
Recall Event ID 96891
Product Classification Emergency response safety kit - Product Code OKI
ProductBroselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700REA AirLife brand, 2025 Edition, and 36-23446 Rev 2 Print Version The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care.
Code Information UDI-DI EA: 10889483588970 CS: 30889483588974 Lot 0004316661
Recalling Firm/
Manufacturer		 SunMed Holdings, LLC
2710 Northridge Dr Nw Ste A
Grand Rapids MI 49544-9112
For Additional Information ContactJessica Hoke
616-259-8400
Manufacturer Reason
for Recall		The impacted tape was manufactured with incorrect information on the tape. Incorrect values are printed in the Red zone, Orange zone, and Grey zone. Using the incorrect values in the Red zone could lead to shocking a patient with an excessive dose of joules, causing significant harm including burns, heart damage, and cardiac arrest. Incorrect values in the Orange zone could lead to overdosing the patient with sodium bicarbonate and cause metabolic alkalosis, electrolyte imbalances, tissue damage, and worsen respiratory status. Incorrect information in the Grey may lead to underdosing the patient with sodium bicarbonate and may cause reduced myocardial contractility, decreased response to vasopressors, and increased risk of dysrhythmia.
FDA Determined
Cause 2		Process control
ActionOn May 15, 2025, the firm began notifying customers via Urgent Medical Device Recall letters. Customers were given detailed information about the incorrect information printed on the tape. Customers were instructed to identify and quarantine all affected product in inventory. Customers should destroy and dispose of all affected product. If product was further distributed, distributors should identify their customers/consignees and notify them of the recall. The firm will provide replacement products once customer confirms destruction of affected product.
Quantity in Commerce9900 eaches
DistributionUS distribution nationwide. International distribution to Canada.
Total Product Life CycleTPLC 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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