The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2419-2023·Announced 2023-08-23

Surgical clamp rotation knob may crack or break due to manufacturing defect

Specific lots of Snowden-Pencer surgical clamps may have rotation knobs that crack or break due to incorrect adhesive use in manufacturing. Eight units with lot numbers L22, B23, or C23 distributed in the US and Canada are affected.

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: This is a FDA Class II medical device recall where a critical component can crack or break due to manufacturing defect. Although no injuries or hospitalizations have been reported, this surgical instrument's potential failure during use presents a risk of harm. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported, warranting a High severity rating.

Plain-English summary

Carefusion 2200 Inc is recalling specific lots of Snowden-Pencer MIS Diamond-Touch clamps used in endoscopic surgery. The recall involves eight units with UDI/DI 10885403160547 and lot numbers L22, B23, and C23.

The rotation knobs on affected units have the potential to crack or break due to incorrect adhesive use during the manufacturing process. This defect could affect the instrument's functionality during surgical use.

Affected lot numbers L22, B23, and C23 were distributed to the US and Canada. Healthcare facilities and practitioners using this product should verify their lot numbers against the recall notice.

The recalled product

Product
Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 25 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7043; endoscopic surgical device
Manufacturer
Carefusion 2200 Inc
Category
Medical Device — Surgical Instruments
Hazard
Affected units
8

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 (4)

  • UDI/DI 10885403160547
  • Lot Numbers: L22
  • B23
  • C23

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 15 recalled by Carefusion 2200 Inc 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.

See all 15 products in this recall →

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