Medline MICRODISECTOMY PACK recalled for endotoxin contamination
Medline custom MICRODISECTOMY PACK kits containing non-sterile Codman Surgical Patties and Strips with potential endotoxin contamination are being recalled. Approximately 1,494 units were distributed in the US, UAE, and Canada.
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: FDA Class II medical device with non-sterile surgical components presenting endotoxin contamination risk. No illnesses or injuries reported; however, potential contamination of surgical fields during microdisectomy procedures represents a risk-of-harm situation requiring Class II recall status.
Plain-English summary
Medline Industries, LP is recalling custom medical procedure kits under the product name MICRODISECTOMY PACK (available as REF DYNJ80585A and REF DYNJ80585B). The kits are being recalled because they contain non-sterile Codman Surgical Patties and Surgical Strips, which have the potential for endotoxin contamination.
Approximately 1,494 units have been distributed worldwide in the United States, United Arab Emirates, and Canada. Both product variants have multiple lot numbers included in this recall.
The recalled product
- Product
- Medline custom medical procedure kits labeled as: 1) MICRODISECTOMY PACK, REF DYNJ80585A; 2) MICRODISECTOMY PACK, REF DYNJ80585B.
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Kits
- Affected units
- 1,494
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 DYNJ80585A
- UDI/DI 10195327063948 (EA) 40195327063949 (CS)
- Lot Numbers: 22ABF513
- 22DBK159
- 22DBL699
- 22FBQ597
- 2) REF DYNJ80585B
- UDI/DI 10195327211158 (EA)
- 40195327211159 (CS)
- Lot Numbers: 22GBV101
- 22HBG177
- 22HBU871
- 23ABD760
- 23BBE037
- 23GBL753
- 23GBV443
- 23HBU815
- 23IBJ525
- 23JBO457
- 23LBD006
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 18 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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