Medline Rhinoplasty Pack kits recalled for potential breather pouch seal failures
Medline is recalling Rhinoplasty Pack convenience kits (Model DYNJ27333F) due to potential open or weak seals on breather pouches used to package the sterile kits.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
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: FDA Class II recall of a sterile medical device with a packaging integrity issue (potential seal failure) that poses a risk of contamination of a sterile product. No reported illnesses or injuries are stated, but compromised sterility on surgical kits presents a direct risk of harm.
Plain-English summary
Medline Industries, LP is recalling Rhinoplasty Pack convenience kits, Model Number DYNJ27333F, due to a potential for open or weak seals on the breather pouches used for packaging these sterile convenience kits.
The affected product is lot number 24KBH228 with UDI-DI 10888277055292 (each unit) and 40888277055293 (case). A total of 56 units have been distributed worldwide, including throughout the United States and to Canada, Mexico, Panama, and the U.S. Virgin Islands.
Consumers who have received this product should discontinue use. Patients and healthcare providers with questions or concerns about this product should contact Medline Industries, LP in Northfield or consult the FDA for further guidance.
The recalled product
- Product
- Medline Convenience kits used for various procedures: 1) RHINOPLASTY PACK, Model Number: DYNJ27333F
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 56
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 (4)
- 1) DYNJ27333F
- UDI-DI: 10888277055292(each)
- 40888277055293(case)
- Lot Number: 24KBH228
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 34 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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