EXP Pharmaceutical Services Recalls TAUT Intraducer Peritoneal Catheters
EXP Pharmaceutical Services Corp is recalling TAUT Intraducer Peritoneal Catheters because the company failed to register as a medical device establishment or maintain its own quality system.
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: The recall is classified as FDA Class II, which indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The rubric assigns a score of 3 to high-risk products where injury has not yet been reported.
Plain-English summary
EXP Pharmaceutical Services Corp is recalling six units of TAUT Intraducer Peritoneal Catheters (2mm x 1.6mm x 7.6cm) and associated sterile pouches. The devices are identified by OEM Catalog number PI-63 and were repackaged by EXP Pharmaceutical Services Corp.
The recall was initiated because EXP did not register as a medical device establishment, did not list the devices being recalled, and did not establish its own quality system. Instead, the company relied on its vendors being registered and having their own quality systems. This is classified as an FDA Class II recall.
The affected units were distributed in the District of Columbia and the states of Colorado, California, Florida, Texas, and Arkansas. Consumers and healthcare providers should stop using these devices and contact EXP Pharmaceutical Services Corp for further instructions.
The recalled product
- Product
- Medical Device Exchange TAUT Intraducer Peritoneal Catheter 2mm x 1.6mm x 7.6cm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number PI-63; EXP (repackager), Teleflex (OEM) Catheter, biliary, surgical
- Manufacturer
- EXP Pharmaceutical Services Corp
- Category
- Medical Device — Catheters
- Affected units
- 6
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 (1)
- OEM Catalog number PI-63.
Distribution
Part of a larger recall action
This product is one of 42 recalled by EXP Pharmaceutical Services Corp 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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