Recall Z-0358-2017— Unomedical As
Class II · Terminated
Class II FDA medical device recall by Unomedical As, initiated 2014-11-07, terminated 2016-11-16. It names 2 FDA 510(k) clearances: K120872, K972135. Product: Comfort 5+5 Pack w/110cm Tube & 17mm Cann. UPC# 3-89110-14147-7; Comfort 5+5 Pack w/60cm Tube & 17mm Cann. UPC# 3-89110-14127-9; Comfort 5+5 Pack w/110cm Tube & 13mm Cann. UPC# 3-89110-14143-9; Conform 5+5 Pack w/60cm Tube & 13mm Cann. UPC# 3-89110-14123-1 The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin. Reason: Tubing detachment.
- Recalling firm
- Unomedical As
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-11-07
- Terminated
- 2016-11-16
- Firm location
- Roskilde, Denmark
510(k) clearances named in this recall
2 on FDA's record- K120872 — ASANTE CONSET AND ASANTE COMFORT SUBCUTANEOUS INFUSION SETS FOR USE WITH ASANTE PEARL INFUSION PUMPS
- K972135 — MAERSK MEDICAL PURELINE COMFORT SUBCUTANEOUS INFUSION SET
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Comfort 5+5 Pack w/110cm Tube & 17mm Cann. UPC# 3-89110-14147-7; Comfort 5+5 Pack w/60cm Tube & 17mm Cann. UPC# 3-89110-14127-9; Comfort 5+5 Pack w/110cm Tube & 13mm Cann. UPC# 3-89110-14143-9; Conform 5+5 Pack w/60cm Tube & 13mm Cann. UPC# 3-89110-14123-1 The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
Reason for recall
Tubing detachment
Data sourced from openFDA. This site is unofficial and independent of the FDA.