510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Telcare, LLC

Linwood, PA, US

Telcare, LLC appears in FDA device records in Linwood, PA. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 1 510(k) clearance for Telcare, LLC in 2011.

Clearances by year, as a table
510(k) clearance decisions for Telcare, LLC, by decision year
YearClearances
20111
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K110571TELCARE BLOOD GLUCOSE MONITORING SYSTEM, TEST STRIPS, CONTROL SOLUTIONS, TELSERVE-HOME USE, TELSERVE-PROFESSIONAL USENBWSubstantially Equivalent

Registered establishments

FDA registered establishments for Telcare, LLC, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30085143953008514395Telcare, LLC600 West Ridge Road, Suite 200, Linwood, PA 19061 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1270-2025Philips Connected Blood Glucose Meter, BGM 4; Model Number: TM0009;Telcare, LLC has received customer complaints related to battery expansion/swelling for its Philips Connected Blood Glucose Meter (i.e., BGM 4 brand name) Monitoring System.. The issue was identified by post market surveillance data (customer complaints) - events of battery expansion/swelling and associated symptoms, e.g., leading to the device's removable back cover (battery port) to separate. If there is a loss of primary function of the device due to the described device defect, an immediate health consequence that may result is prolonged hypoglycemia or hyperglycemia due to delay in treatment, as the blood glucose measurement is not available to guide treatment. In a worst-case situation, there is potential for battery swelling to result in explosion of the battery and/ or device. Exposure to explosion, and subsequently projectiles from the explosion, may result in several immediate health consequences, including concussion, headache, dizziness, eye irritation, blurred vision, eye injury, and vision impairment.Class IIOpen, Classified

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain