[pending] MEDLINE convenience kits labeled as: 1) GENERAL AAA #11-RF, REF CDS840261AB; 2) CAROTID ENDARTE
Pending LLM rewrite. Source: FDA_DEVICE Z-0513-2026.
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: Pending LLM scoring against the rubric.
Plain-English summary
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.
The recalled product
- Product
- MEDLINE convenience kits labeled as: 1) GENERAL AAA #11-RF, REF CDS840261AB; 2) CAROTID ENDARTERECTOMY CDS-LF, REF CDS983637I; 3) PERIPHERAL VASCULAR CDS, REF CDS983723J; 4) ACH OPEN HEART, REF CDS983773J; 5) VASCULAR, REF CDS984255K; 6) OPEN HEART CHILDRENS PACK-LF,
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Devices
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) CDS840261AB: UDI/DI 10195327104535 (each)
- 40195327104536 (case)
- Lot Numbers: 23FBF165
- 23JBM632. 2) CDS983637I: UDI/DI 10195327228125 (each)
- 40195327228126 (case)
- Lot Numbers: 23GBU191. 3) CDS983723J: UDI/DI 10195327327828 (each)
- 40195327327829 (case)
- Lot Numbers: 23FBA013
- 23FBH486
- 23GBE805. 4) CDS983773J: UDI/DI 10195327233617 (each)
- 40195327233618 (case)
- Lot Numbers: 23GBT133
- 23HBH924
- 23HBL135
- 23HBV936. 5) CDS984255K: UDI/DI 10193489288605 (each)
- 40193489288606 (case)
- Lot Numbers: 23KBU348
- 24ABB883
- 24ABS338. 6) DYNJ0161262C: UDI/DI 10195327357283 (each)
- 40195327357284 (case)
Distribution
Distributed nationwide across the United States.
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