Medline medical procedure kits recalled for dimensional variation affecting canister fit
Medline Industries recalled 6,998 medical procedure kits worldwide due to slight dimensional variations that may cause difficulty fitting into outer canisters. The Class II recall affects multiple procedure kit types distributed in the US and internationally.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall without any reported illnesses or injuries. The hazard is a potential functional defect (dimensional variation affecting fitment) rather than an imminent safety emergency. Per the severity rubric, risk-of-harm products where injury has not yet been reported are classified as High (score 3).
Plain-English summary
Medline Industries, LP has recalled 6,998 medical procedure kits distributed worldwide. The affected kits include multiple types: BASIC NASAL, BRONCH KIT, ENT, NASAL SINUS-LF, ORAL, PACK BRONCHOSCOPY, PACK HEAD AND NECK, PACK SINUS, PACK T & A, PACK T & A ASC, and T AND A models, with multiple lot numbers for each type.
The kits are being recalled due to a slight dimensional variation in their construction. This variation has the potential to cause increased difficulty when fitting the kits into their outer canisters.
The recalled kits were distributed worldwide, including throughout the United States and internationally to Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, and Singapore.
The recalled product
- Product
- Medline medical procedure kits labeled as follows: a) BASIC NASAL, REF DYNJ909932; b) BRONCH KIT, REF DYKE1007B; c) ENT, REF DYNJ909935; d) NASAL SINUS-LF, REF DYNJ902624G; e) ORAL, REF DYNJ902377I; f) PACK,BRONCHOSCOPY, REF DYNJ65475B; g) PACK,HEAD AND NECK, REF
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 6,998
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)
- a) REF DYNJ909932
- UDI/DI 40195327511167 (case)
- 10195327511166 (unit)
- Lot Numbers: 23JBI290
- 23KBI103
- b) REF DYKE1007B
- UDI/DI 40195327203697 (case)
- 10195327203696 (unit)
- Lot Numbers: 22HBF709
- 22HBV977
- 22LBC080
- 22LBH793
- 23CBP363
- 23DBL601
- 23EBT148
- 23FBS311
- 23GBP583
- 23HBY932
- 23JBK265
- c) REF DYNJ909935
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 21 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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