Personal Intermittent Catheters- 16" and 10" lengths — Class II medical device recall Z-1309-2018
Terminated recall by C.R. Bard, Inc., reported 2018-04-11, distributed nationwide. Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were ob
| Recall number | Z-1309-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | C.R. Bard, Inc., Covington, GA, United States |
| Recall initiated | 2017-09-14 |
| Classified | 2018-04-04 |
| Reported by FDA | 2018-04-11 |
| Terminated | 2019-11-05 |
| Distributed | Nationwide (US) |
| Quantity | 10,949,013 units |
| Reason classes | sterility, packaging |
| Lot numbers | 50612, 50614, 50616, 50618, 52306, 52308, 52310, 52606, 52606G, 52608, 52608G, 52610, 52610G, 53314, 53320, 53514G, 53610, 53610G, 53612G, 53614G, 53616G, 53617349, 53618G, 53621167, 53621355, 602608, 62308, 62310, 62606P, 62608P, 62610, 62610P, 63310, 63316, 63610, 63610M, 63612, 63612M, 63614, 63614M and 445 more |
| Model numbers | 50612, 50614, 50616, 50618, 52306, 52308, 52310, 52606, 52606G, 52608, 52608G, 52610, 52610G, 53314, 53320, 53514G, 53610, 53610G, 53612G, 53614G, 53616G, 53618G, 602608, 62308, 62310 and 21 more |
Product
Personal Intermittent Catheters- 16" and 10" lengths - 30 catheters per box, each catheter is packaged in an individual pouch, Item Numbers: 50612, 50614, 50616, 50618, 52306, 52308, 52310, 52606, 52606G, 52608, 52608G, 52610, 52610G, 53314, 53320, 53514G, 53610, 53610G, 53612G, 53614G, 53616G, 53618G, 62308, 62310, 62606P, 602608, 62608P, 62610, 62610P, 63310, 63316, 63610, 63610M, 63612, 63612M, 63614, 63614M, 63616, 63616M, 63618, 71410, 72608, 72610, 73612, 73614, 73616 Product Usage Intermittent catheters are intended for urinary bladder drainage in patients requiring catheterization for management of incontinence, voiding dysfunction, and surgical procedures.
Reason for recall
Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1309-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.