ScottCare TeleSentry Battery Recall Due to Explosion Risk During Recharging
ScottCare is recalling 9,067 TeleSentry batteries after a complaint that one exploded while recharging. The batteries are used in cardiac monitoring devices.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the source text reports a specific incident of a battery exploding, which constitutes a significant injury/property-damage report under the rubric for a score of 4.
Plain-English summary
ScottCare Corporation is recalling 9,067 TeleSentry 3.7 Li-Ion Polymer batteries. The recall was initiated after the firm received a complaint that a battery exploded while it was being recharged. The affected batteries are intended for use in diagnostic evaluation of patients who experience transient symptoms or asymptomatic events that may suggest cardiac arrhythmia.
The recall covers Model # TS01, Part #101109, with specific serial numbers ranging from 27313 to 38852. The batteries were distributed worldwide, including in the United States and Canada. The source text does not specify the exact number of affected patients or the specific dates of distribution.
Consumers and healthcare providers should check their inventory for these specific serial numbers. If a battery is found, it should be removed from service and returned to ScottCare Corporation for replacement or refund. The source text does not provide specific contact information for the recall, but users should refer to the official FDA recall notice for detailed instructions.
The recalled product
- Product
- TeleSentry Battery, 3.7 Li-Ion Polymer Battery, CAUTION Do not expose to high temperature. Do not disassemble. Dispose of properly. Use specified charger only. 60pC/140pF The ScottCare Corporation. Intended for diagnostic evaluation of patients who experience transient…
- Manufacturer
- Scottcare Corporation
- Affected units
- 9,067
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)
- Model # TS01
- Part #101109
- Serial #'s: 27313
- 27314
- 27315
- 27316
- 27317
- 27318
- 27319
- 27320
- 27321
- 27322
- 27323
- 27324
- 27325
- 27326
- 27327
- 27328
- 27329
- 27330
Distribution
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