MEDLINE circumcision kits recalled due to defective smoke evacuation component
MEDLINE is recalling circumcision kits manufactured with SafeAir Smoke Evacuation Pencils that were previously recalled by Stryker. No injuries have been reported.
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 recall where kits contain a component subject to recall by its original manufacturer. Although no injuries or illnesses have been reported, this meets the rubric criterion of 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
MEDLINE Industries is recalling three models of circumcision convenience kits: CIRCUMCISION PACK (REF DYNJ16826O), D-CIRCUMCISION PACK (REF DYNJ64432), and PACK, CIRCUMCISION ASC (REF DYNJ906909A). A total of 828 units have been distributed nationwide in the US.
The kits are being recalled because they were manufactured using certain lots of SafeAir Smoke Evacuation Pencils, a component that was subsequently recalled by Stryker, its original manufacturer.
No injuries or illnesses have been reported in connection with this recall. Healthcare facilities and patients with these kits should contact MEDLINE for instructions on device return, replacement, or proper disposition.
The recalled product
- Product
- MEDLINE convenience kits labeled as: 1) CIRCUMCISION PACK, REF DYNJ16826O; 2) D-CIRCUMCISION PACK, REF DYNJ64432; 3) PACK,CIRCUMCISION ASC, REF DYNJ906909A
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- defective-component
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 DYNJ16826O
- UDI/DI 10195327412067 (each) 40195327412068 (case)
- Lot Numbers: 23FMC064
- 2) REF DYNJ64432
- UDI/DI 10193489814255 (each) 40193489814256 (case)
- Lot Numbers: 22CDC116
- 22DDC463
- 22JDA234
- 22KDA275
- 23BDA297
- 23DDC249
- 23FDB680
- 3) REF DYNJ906909A
- UDI/DI 10195327303532 (each) 40195327303533 (case)
- Lot Numbers: 23DBD597
- 23DBE346
- 23ABE857
- 23KBH128
- 23IBC034
- 24ABT698
Distribution
Distributed nationwide across the United States.
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