Disposable 5 Lead Cable System May Contain Non-Approved ECG Leads
Stryker Sustainability Solutions is recalling disposable 5 lead cable systems that may contain non-approved ECG leads which were improperly reprocessed. The wrong components may cause devices to malfunction.
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 medical device recall where potentially non-approved ECG leads may have been improperly reprocessed, creating a risk of device malfunction. No illnesses or injuries have been reported, and the hazard remains theoretical, placing this at the High severity level.
Plain-English summary
Stryker Sustainability Solutions is recalling Disposable 5 Lead Cable and Lead Wire Systems (model LW-309DS50/5A) distributed nationwide. The recalled packages should contain approved lead systems and dual connect cables, but may instead contain different ECG leads that are not approved for reprocessing.
The non-approved ECG leads in the affected packages may have been reprocessed. Because these specific leads are not designed to be reprocessed, they may not perform correctly when used, potentially affecting patient monitoring during medical procedures.
Approximately 38,850 units were distributed across 12 states: Florida, Wyoming, Arizona, California, Louisiana, Texas, Michigan, Oregon, Colorado, Mississippi, Tennessee, and Wisconsin.
Healthcare facilities that have received these cables should check their inventory against the provided lot numbers. If you have the recalled product, contact Stryker Sustainability Solutions immediately. Do not use these devices if they contain non-approved ECG leads.
The recalled product
- Product
- Disposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5A
- Manufacturer
- Stryker Sustainability Solutions
- Affected units
- 38,850
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)
- UDI-DI: 07613327483918
- Lots: 0000111423
- 0000115940
- 0000117907
- 0000124226
- 0000129992
- 0000169328
- 0000176893
- 0000178122
- 0000181676
- 0000206244
- 0000210519
- 0000211431
- 0000213251
- 0000217965
- 0000219223
- 0000221089
- 0000228136
- 0000231266
- 0000236744
Distribution
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