Medline recalls surgical kits containing Stryker smoke evacuation pencil component
Medline is recalling medical convenience kits containing SafeAir Smoke Evacuation Pencils that were previously recalled by Stryker.
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 recall of surgical convenience kits containing a previously recalled smoke evacuation component. Although no illnesses or injuries are reported in the source text, surgical equipment that may not properly function during procedures poses a risk to patient and staff safety.
Plain-English summary
Medline Industries, LP is recalling medical convenience kits that include SafeAir Smoke Evacuation Pencils manufactured by Stryker. These smoke evacuation pencils were previously recalled by Stryker.
The recalled convenience kits were distributed nationwide in the United States. The FDA has classified this as a Class II recall.
Healthcare facilities and consumers should immediately stop using the affected kits and contact Medline Industries for return and replacement instructions.
The recalled product
- Product
- MEDLINE convenience kits labeled as: 1) ORTHO LAMINECTOMY-LF, REF CDS780112J; 2) NEURO CRANIOTOMY CDS #36-RF, REF CDS780119V; 3) BASIC BACK CDS, REF CDS780147N; 4) INSTRUMENTED BACK CDS, REF CDS780148Q; 5) INSTRUMENTED BACK CDS, REF CDS780148R; 6) TOTAL HIP, REF CDS920027W
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 252,162
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)
- 86OJF 1) REF CDS780112J
- UDI/DI 10195327009663 (each) 40195327009664 (case)
- Lot Numbers: 22FBF455
- 23CBH389
- 23FBO500
- 2) REF CDS780119V
- UDI/DI 10195327114916 (each) 40195327114917 (case)
- Lot Numbers: 22KBN442
- 22HBO015
- 23ABF941
- 23DBE182
- 23BBQ326
- 3) REF CDS780147N
- UDI/DI 10195327268770 (each) 40195327268771 (case)
- Lot Numbers: 23DBT165
- 22JBU233
- 23BBJ852
- 4) REF CDS780148Q
- UDI/DI 10193489202939 (each) 40193489202930 (case)
- Lot Numbers: 22JBL294
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 28 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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