Drainage catheter trays recalled over safety indicators showing the wrong position
Bard Peripheral Vascular is recalling 1,240 Safe-T-Centesis 6 Fr Catheter Drainage Trays because the safety indicator can show the catheter in the sharp position when it is blunt.
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: Scored 3 under the risk-of-harm criterion: the firm states a misleading position indicator may cause injury to internal organs or vessels, and no injuries are reported.
Plain-English summary
The Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF PIG1260T, from Bard Peripheral Vascular Inc, is being recalled. The acute drainage catheters are indicated for use in removing fluid during acute drainage or aspiration procedures.
The devices were manufactured with safety indicators that erroneously show the catheter in the sharp position when the catheter is in the blunt position. The firm states this may lead users to believe the device is not yet in the pleural or peritoneal space when it is, which may cause discomfort, delay to treatment, or injury to internal organs or vessels.
The record lists 1,240 units, with lot and expiration data recorded in the enforcement record including UDI 10885403108365. Distribution was nationwide in the United States, in California, Minnesota, Indiana, Michigan and Louisiana. The FDA has classified the action as Class II.
Facilities should quarantine affected stock and follow the firm's instructions.
The recalled product
- Product
- Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T,
- Manufacturer
- Bard Peripheral Vascular Inc
- Affected units
- 1,240
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)
- (01)10885403108365(17)271130 (10)0001623069/0001623069/20271130
Distribution
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