Medline Medical Convenience Kits Recalled for Defective Endotracheal Tubes
Medline is recalling multiple medical convenience kits distributed in California that contain defective intubation endotracheal tubes previously recalled by the manufacturer Smiths Medical. The affected kits are used for neonatal and pediatric resuscitation and intubation procedures.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall of medical devices used in critical neonatal and pediatric resuscitation procedures. Class I recalls are inherently severe due to the reasonable probability of serious adverse health consequences or death, and medical devices used for life-sustaining intubation in vulnerable populations carry significant risk if defective.
Plain-English summary
Medline Industries, LP is recalling 1,550 units of multiple medical convenience kits distributed in California. The kits contain Intubation ORAL/NASAL Endotracheal Tubes manufactured by Smiths Medical, which were the subject of a separate recall by that manufacturer.
The recalled kits include Neonatal Intubation Trays, Newborn Resuscitation Kits, Pediatrics Intubation Trays, and Peds Grey-Pink-Red and Peds Purple variants, identified by various reference numbers including ACC010371C, ACC010381A, ACC010381B, ACC010381C, ACC010395, ACC010397, ACC010541A, ACC010541B, ACC010541C, and DYNJAA252. Multiple lot numbers are affected across these products.
Consumers and healthcare facilities that received these kits should cease use and contact Medline Industries for instructions on return or replacement. Affected facilities should review their inventory using the reference numbers and lot numbers provided to identify potentially recalled units.
The recalled product
- Product
- Medline medical convenience kits labeled as: 1) NEONATAL INTUBATION TRAY, REF ACC010371C; 2) NEWBORN RESUSCITATION KIT, REF ACC010381A; 3) NEWBORN RESUSCITATION KIT, REF ACC010381B; 4) NEWBORN RESUSCITATION KIT, REF ACC010381C; 5) PEDS GREY-PINK-RED, REF ACC010395…
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- Affected units
- 1,550
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 1) REF ACC010371C: UDI/DI 10193489268188 (ea) 40193489268189 (case)
- Lot Numbers: 20DDA921
- 20EDC042
- 20IDC153
- 21ADB113
- 21CDB435
- 21HDB557
- 21JDA180
- 21LDB244
- 22HDB092
- 22IDA205
- 22JDA908
- 22KDA049
- 22LDA351
- 23EDC611
- 2) REF ACC010381A: UDI/DI 10193489800944 (ea) 40193489800945 (case)
- Lot Numbers: 20BDB854
- 20FDA703
- 3) REF ACC010381B: UDI/DI 10193489457803 (ea) 401934894578049 (case)
- Lot Numbers: 20LDA314
Distribution
Distributed in 1 state:
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